Nova Stat Profile pHOx Training manual

Training Manual

Stat Profile pHOx Training Record

Instructor's Name: ___________________________________

Trainee's Name: ___________________________________

12

3

4

5

6

7

8

9

0

Date Completed/Initials

DWG #10-1016A

Handling and Running Patient Samples .............................................. ___________________

Handling and Running Controls ......................................................... ___________________

Replacing the Reagent Pack and Paper ............................................. ___________________

Identifying Flow Path and System Components .................................. ___________________

Calibrating the Analyzer ................................................................... ___________________

Daily Maintenance ........................................................................... ___________________

Troubleshooting ............................................................................... ___________________

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 System Overview .....................................................................1-1

1.2 Flow Overview......................................................................... 1-3

1.2.1 Reagents ......................................................................1-3

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

2 Running an Analysis ...................................................................... 2-1

2.1 Is the Instrument Ready for Analysis?.....................................2-1

2.1.1 Home Screen ...............................................................2-1

2.2 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

2.3 Sample Information..................................................................2-4

2.4 Results Screen and Printout .....................................................2-4

2.5 Running an Analysis Exercise .................................................2-4

2.6 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 Home Screen - Ready for Analysis..........................................3-1

3.2 Questionable Results................................................................ 3-1

3.3 System Status Screen ...............................................................3-1

4 Calibrating the Analyzer ....................................................... 4-1

4.1 Full 2-Point Calibration - all except Hb and SO

4.2 Calibration Timing ...................................................................4-1

4.3 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

5.2 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

5.3 When to Use .............................................................................5-2

5.4 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

5.5 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

.......................

2

4-1

6 Replacing Reagents and Paper .............................................. 6-1

6.1 When to Replace ......................................................................6-1

6.2 How to Replace ........................................................................6-1

6.3 Replacing the Reagent Pack.....................................................6-1

6.4 Replacing the Control Pack......................................................6-1

6.5 Replacing the Printer Paper......................................................6-1

7 Troubleshooting ................................................................... 7-1

7.1 Sensor Screens .........................................................................7-1

7.2 System Test .............................................................................. 7-1

7.3 Error Log ..................................................................................7-2

7.4 Flow Related Problems ............................................................ 7-2

7.5 Sensor Problems.......................................................................7-3

7.6 Results Related Problems.........................................................7-3

7.7 Miscellaneous Problems - Operational ....................................7-3

7.8 Call Nova..................................................................................7-3

TOC-2 PN 24302 Rev. B 7/2001

Table of Contents Stat Profile pHOx Training Manual

8 Flow Test and Flushing ......................................................... 8-1

8.1 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

8.2 Flushing the Entire Flow Path..................................................8-9

8.3 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 Overview ................................................................................10-1

10.2 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 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

12.2 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

13.2 Inputting Selections................................................................13-2

13.3 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

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

A.2 Ordering Parts ......................................................................... A-3

A.2.1 Recommended Spare Parts......................................... A-3

A.3 Warranty Replacements .......................................................... A-4

A.4 Emergency (After Hours) Parts Shipments.............................A-4

A.5 Reaching your Nova Sales Representative ............................. A-4

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 9.1 - 11.6

PCO
PO

2

SO

2

+

Na

2

(-15.0) - ( -1.6)

7.9 - 12.6

6.9 - 18.2

8.8 - 11.5

Hct 12.0 - 50.0

Measurement Range:

pH 6.50 - 8.00 pH units H+ 316.23 - 10.00 nmol/L

PCO
PO

2

SO

2

2

3.0 - 200 mmHg 0.4 - 26.7 kPa
0 - 800 mmHg 0.0 - 106.7 kPa

0.0 - 100 % 0.0 - 1.0

Hb 4.0 - 24.0 g/dL 40.0 - 240.0 g/L 2.5 - 14.9 mmol/L
Hct 12 - 70 %

Dependency Rule and Information:

Hct Requires Na+ calibrated for calibration/results.

PCO
SO

2

2

Requires pH calibrated for results. (pH is checked on standards to assure bicarb is correct.)
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 PO

between 30 and 75 mmHg.

2

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

Weekly

Monthly

Quarterly

NOTE:

For the BioProfile pHOx, SO2 is not applicable.

Reposition Tubing in Pinch Valves
Record Slopes

Calibrate SO2

Clean SO2 Sensor and Cuvette
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 SO2
PO2/PCO2

Results High Verify controls are at room temperature
or Low

Check for low slope
Change membrane
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
Check for air leak in system
Clean probe and preheater
Check waste line for restrictions Change reference electrode

Results High Recalibrate, clean cuvette and sensor,
or Low inspect or replace washer

pH

Condition sensor module w/whole blood
Verify reference solution delivery
Change pH sensor

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 9.1 - 11.6

PCO

2

PO

(-15.0) - (-1.6)

2

Measurement Range:

pH 5.00 - 8.00 pH units

PCO

2

PO

2

BarP 400.0 - 800.0 mmHg 53.3 - 106.7 kPa 15.7 - 31.5 inHg

7.9 - 12.6

3.0 - 200 mmHg 0.4 - 26.7 kPa
0 - 800 mmHg 0.0 - 106.7 kPa

Dependency Rule and Information:

PCO

2

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

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.

®

pHOx® Customer Training Programs

NOTES:

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

(800) 545-NOVA ext. 571

i

Preface Stat Profile pHOx Training Manual

NOTES:

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:

• Adapting the analyzer to the facility’s needs (setup options)

• Guidelines for analyzer performance verification
(See

Getting Your Nova Analyzer On Line

- Linearity

- Precision

- Correlation

• QA Program options

• CLIA compliance

ii

, PN 17361.)

1 System Identification Stat Profile pHOx Training Manual

NOTES:

1 System Identification

1.1 System Overview

• 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

4

8

7

DWG #10-1017A

5

1-2

6

Figure 1.1 Analytical Compartment

1. Waste Line 7. Sampler

2. Reference Line 8. Air Detector

3. Pinch Valve (Reference) 9. Sensor Module with Sensors

4. Pump and Pump Tubing 10. Reference Electrode

5. Reagent Pack Opening 11. Pinch Valve (Waste)

6. Control Pack Opening

1 System Identification Stat Profile pHOx Training Manual

NOTES:

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.

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 shows all
these parts as they
are described.

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

PCO
PO

2

2

Severinghaus-type electrode

Polarographic Clark-type electrode
Hct Impedance electrode
Hb Impedance electrode/photometry

SO

2

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 #7-0-039A

Figure 1.2 Sensor Blank

1.3.10Interconnect Tubing (PN 07161)

Interconnect Tubing is installed between the reference electrode and
the sensor module.
Required for the proper sealing of these components.

1.3.11Barometric 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:

1.3.12Pump 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.

G #10-1007A

DW

Figure 1.3 Pump Manifolds and Tubing

1-7

1 System Identification Stat Profile pHOx Training Manual

NOTES:

1-8

2 Running an Analysis Stat Profile pHOx Training Manual

NOTES:

2 Running an Analysis

2.1 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.

For whole blood

2.2 Patient Samples — Acceptable Samples/Sample Handling

analysis only.

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.

No serum or plasma

unless operator has

validated the system

for that purpose.

No urine, CSF,

cardioplegia solution,

or other body fluids.

Update to PN 24302 Rev. B 3/2002

2-1

2 Running an Analysis Stat Profile pHOx Training Manual

NOTES:

This means no EDTA
(purple tops), NaF
(gray tops), or
uncentrifuged red
tops.

A general rule of thumb
for blood gas and
electrolyte analysis is
to run the sample
within 15 minutes of
the time it was
collected.

P

O2.... may increase in a

blood sample collected
into a plastic syringe
and stored on ice. The
NCCLS document
C32-P discusses
these increases.

2.2.2 Acceptable Anticoagulants

Sodium and lithium heparin resulting in a final concentration of not more
than 20 I.U. per mL in blood are the only acceptable anticoagulants.

2.2.3 Syringe Handling Tips

1. Remove air at time of collection.

2. Mix sample thoroughly by rolling between hands.

3. Run as soon as possible after collection. Do not ice plastic
syringes.*

4. Check for clots by expelling a drop of blood onto a gauze
pad.

5. For repeat samples, expel any air left in syringe.

6. Position sample so that probe tip stays deep in the syringe
but not touching the syringe plunger.

* NCCLS. Nov., 1993. Considerations in the simultaneous measurement of blood gases,
electrolytes and related analytes in whole blood., NCCLS document C32-P. Vol. 13, No. 17.

2-2

2 Running an Analysis Stat Profile pHOx Training Manual

NOTES:

2.2.4 Capillary Handling Tips

• Collect in heparinized capillary tubes only.

• Place metal “flea” (stirring bar) in capillary prior to collect­ing sample.

• Sample must be collected without air spaces or gaps in
capillary.

• Using magnet, mix well after collection.

• Cover tube ends with removable caps (not clay seal) for
transportation to lab.

• See additional notes in Chapter 1 of the Reference Manual.

2.2.5 Sample is Presented and Analysis Occurs

Press the White Button (Syringe) or the Black Button (Capillary) to
run an analysis. The Aspirate screen displays. Wait until the sample
probe is in position. Present the sample to the probe.

Instructor

demonstrates

analysis.

Samples can be presented in a syringe, opened vacuum tube, sample
cup, or capillary.

Probe

Syringe

G #10-1024A

DW

Figure 2.1 Syringe Sample Presentation

2-3

2 Running an Analysis Stat Profile pHOx Training Manual

NOTES:

After the sample is positioned, press Continue (soft Key). (If not
pressed within 45 seconds, the analyzer returns to the Ready screen.)

In STAT Mode
Analysis, the Sample
Information screen is
not displayed. The
ABG Results­Measured screen is
displayed after
aspiration is
completed.

If the view results soft
key is not selected the
analysis will not go to
completion. No results
will be displayed or
printed out.

NOTE:

If you attach an
external key board,
alpha keys are
available.

2.3 Sample Information

2.4 Results Screen and Printout

The pump turns, pulling the sample through the probe, air detector
tubing, and sensor module. A pop-up screen appears. Remove the
sample from the probe. Press Analyze. (If Analyze -soft key- is not
pressed within 30 seconds, the probe will automatically move down­ward.) The probe moves downward.
The analyzer displays the Sample Information screen with a bar graph
until completion.
Input sample information, then press View Results to see the com­pleted results.

The Sample information screen is displayed after aspiration has been
completed. This screen allows you to enter Accession number,
Operator ID, Patient ID number, Combine with CO-Oximeter, com­bine with last sample for A/V & Shunt results, Patient temperature,
and Sample Type. Use arrow keys to move to next option; Use the
number keys or the Enter key to toggle or get pop-up selection.

2-4

The ABG Results -Measured screen is displayed and results fill in the
table as they become available. The results on the screen can be
printed by pressing Print (soft key). Press Next Page (soft key) to go
to the next results screen, etc.

2.5 Running an Analysis Exercise

See Running an Analysis Checklist to perform the lab.

2.6 Standby Mode

See Standby Mode Checklist to perform the lab.

2 Running an Analysis Stat Profile pHOx Training Manual

Running a Syringe Analysis Checklist

NOTES:

Step 1 Check the instrument for readiness.

• Check the display for the Home (Ready) screen.

Step 2 Present sample and begin analysis.

(Procedure for syringes)

• Press the White Syringe Button.

• Probe positions for sample aspiration.
Slide the syringe tip over the extended probe.

CAUTION:

the base of the syringe plunger or the bottom of the
sample cup or tube.

Do not allow the sample probe to touch

Step 3 Analysis begins.

• Press Aspirate Normal (soft key) to start the sampling. (Or,
press Aspirate Micro (soft key) for a smaller sample: 45µL
instead of 70µL.)

NOTE:

5 minutes of the time the probe extends, the probe
automatically starts to move down.

• When the system signals by an audible alarm, withdraw the
sample.

• Press Analyze. The probe moves down.

NOTE:

after the sample has been aspirated, the probe
automatically starts to move down.

If one of these soft keys is not pressed within

If Analyze is not pressed within 30 seconds

• The analysis begins.

• The Sample information screen is displayed.

Update to PN 24302 Rev. B 3/2002

2-5

2 Running an Analysis Stat Profile pHOx Training ManualRunning a Syringe Analysis Checklist

NOTES:

Step 4 Enter patient information.

• The Sample information screen is displayed. (If in STAT
Mode, this screen does not display. Go to next step.)

• Enter patient data.

NOTE:

Press arrow keys to move through options.
Press number keys or Enter key to toggle or get
pop-up screen.

If the View Results
(soft key) is not
pressed, the analysis
will not go to
completion and will not
print out the results.

Step 5 Results are displayed and printed.

• Press View Results (soft key) to view the results.

• Measured results are displayed on the ABG Results ­Measured screen as they become available.
Selected calculated results can be viewed by pressing
Next Page (soft key) from the Results screen.

• To print the results, press Print (soft key).

• Results are transmitted to an optional external printer or
computer, if enabled.

• After transmission and/or printout, all patient information
becomes READ ONLY. They no longer can be changed or
combined.

• Press Home (soft key) to return to the Home (Ready) screen.

2-6

2 Running an Analysis Stat Profile pHOx Training Manual

Running a Capillary Analysis Checklist

NOTES:

Step 1 Check the instrument for readiness.

• Check the display for the Home (Ready) screen.

Step 2 Prepare capillary.

(See Section 2.2.4, Capillary Handling Tips)

• Mix sample again by drawing magnet back and forth along
the length of the capillary.

• Keeping capillary level, remove cap (or caps) from the ends.

• Remove mixing flea by pulling it out one of the free ends
with the magnet.

Step 3 Present sample.

• Press the Black Capillary Button and wait for probe to
position.

• Holding one gloved finger over the open end of the capil­lary, carefully slide the tip of the capillary into the adapter
until it just touches the probe.

• The capillary should be in line with probe, not tilted horizon­tally.

Demo this before

trainees attempt it.

Skip this section if

they do not run

capillaries.

CAUTION: Do not

end of the capillary yet.

Step 4 Begin analysis.

• Press Aspirate Normal (soft key) to start the sampling. (Or,
press Aspirate Micro (soft key) for a smaller sample: 45µL
instead of 70µL.)

NOTE:

5 minutes of the time the probe extends, the probe
automatically starts to move down.

• As soon as the pump starts to turn, remove your finger from the
open end of the capillary, allowing the sample to be drawn up.

Update to PN 24302 Rev. B 3/2002

If one of these soft keys is not pressed within

remove your finger from the open

2-7

2 Running an Analysis Stat Profile pHOx Training Manual

NOTES:

Running a Capillary Analysis Checklist

• When the system signals by an audible alarm, remove the
capillary from the probe and adapter.

• Press Analyze. The probe moves down.

NOTE:

after the sample has been aspirated, the probe
automatically starts to move down.

• The analysis begins.

• The Sample information screen is displayed.

If Analyze is not pressed within 30 seconds

Step 5 Enter patient information.

• The Sample information screen is displayed. (If in STAT
Mode, this screen does not display. Go to next step.)

• Enter patient data.

NOTE:

Press arrow keys to move through options.
Press number keys or Enter key to toggle or get
pop-up screen.

Step 6 Results are displayed and printed.

If the View Results
(soft key) is not
pressed, the analysis
will not go to
completion and will not
print out the results.

• Press View Results (soft key) to view the results.

• Measured results are displayed on the ABG Results ­Measured screen as they become available.
Selected calculated results can be viewed by pressing
Next Page (soft key) from the Results screen.

• To print the results, press Print (soft key).

• Results are transmitted to an optional external printer or
computer, if enabled.

• After transmission and/or printout, all patient information
becomes READ ONLY. They no longer can be changed or
combined.

• Press Home (soft key) to return to the Home (Ready) screen.

2-8

2 Running an Analysis Stat Profile pHOx Training Manual

Running an AV Shunt Analysis Checklist

NOTES:

Step 1 Check the instruments for readiness.

NOTE:

This checklist can only be performed if a
Nova CO-Oximeter is in communication with the
pHOx Analyzer, so that the results can be com­bined. This checklist may be removed if not needed.

• Check the pHOx display for the Home (Ready) screen.

• Check the CO-Oximeter for readiness.
(See the Nova CO-Oximeter Reference Manual.)

Step 2 Present sample and begin analysis.

• Press the White Syringe Button.
Probe positions for sample aspiration.

• Press the AV Shunt (soft key).

• Position the mixed venous sample over the extended probe.

You must press soft

CAUTION:

the base of the syringe plunger or the bottom of the
sample cup or tube.

Do not allow the sample probe to touch

keys within 45

seconds or the cycle

will abort

automatically.

Step 3 Analysis begins.

• Press Aspirate (soft key).

• When the system signals by an audible alarm, withdraw the
sample.

• Press Analyze (soft key). The probe moves down.

• The analysis begins.

• The Sample information screen is displayed; enter patient
data.

NOTE:

Press arrow keys to move through options.
Press number keys or Enter key to toggle or get
pop-up screen.

If Analyze is not
pressed within 30
seconds after the

sample has been

aspirated, the probe

automatically starts

to move down.

2-9

2 Running an Analysis Stat Profile pHOx Training Manual

NOTES:

Running an AV Shunt Analysis Checklist

Step 4 Continue Analysis on CO-Oximeter.

• Analyze the mixed venous sample on the CO-Oximeter.

Step 5 Run the Arterial Sample.

• When the message, Mixed Venous sample complete, posi­tion the arterial sample over the extended probe.

• Press Aspirate (soft key).

• After aspiration, remove arterial sample and press Analyze
(soft key).

Step 6 Continue Analysis on CO-Oximeter.

If the View Results
(soft key) is not
pressed, the analysis
will not go to
completion and will not
print out the results.

• Analyze the arterial sample on the CO-Oximeter.

Step 7 Results are displayed and printed.

• Press View Results (soft key) to view the results.

• Measured results are displayed on the ABG Results ­Measured screen as they become available.
Selected calculated results can be viewed by pressing
Next Page (soft key) from the Results screen.

• To print the results, press Print (soft key).

• Results are transmitted to an optional external printer or
computer, if enabled.

• After transmission and/or printout, all patient information
becomes READ ONLY. They no longer can be changed or
combined.

• Press Home (soft key) to return to the Home (Ready) screen.

2-10

2 Running an Analysis Stat Profile pHOx Training Manual

Standby Mode Checklist

NOTES:

Step 1 Start the procedure.

NOTE:

This option allows you to place the analyzer
into a standby mode and allows you to reactivate
the analyzer out of the mode at a programmed time
and date. The standby mode will use less reagents
and controls because the analyzer will not run its
automatic calibration cycles. Calibration is lost

SO

except for
set time is elapsed, if you initiate a calibration, or if

you turn Standby off.

• From the Operational Menu, scroll down to the Standby
Mode.

• Press ENTER (once if mode is OFF or twice if Mode is ON).

and Hb. Standby mode ends after the

2

Step 2 Set the date.

• Press ENTER (again) - the date becomes blank.

• Key in the date that you want the analyzer to come out of
Standby Mode.

• Press ENTER to set the date. (DO NOT press OK.)

Step 3 Set the time.

• Press any Arrow key to go to the time field.

• Press ENTER - the time becomes blank.

• Key in the time that you want the analyzer to come out of
Standby Mode.

• Press ENTER to set the time. (DO NOT press OK.)

2-11

2 Running an Analysis Stat Profile pHOx Training Manual

NOTES:

Standby Mode Checklist

Step 4a Start the Standby Mode.

• Now press OK (soft key) to initiate the Standby Mode.

• Another pop-up screen appears to verify that you want to go
into Standby Mode. Press OK (soft key) again and the
Standby Mode is officially ON.

Step 4b Cancel the Standby Mode.

• Press Cancel (soft key) to cancel the Standby Mode.

• The date and time fields revert to the previous settings.

• The Standby Mode is now OFF.

2-12

3 Operational Status Stat Profile pHOx Training Manual

NOTES:

3 Operational Status

3.1 Home Screen - Ready for Analysis

Indicates readiness of the analyzer.

• All analytes are shown. Uncalibrated analytes are x'd out and
a — (a line through an analyte prefix) when the channel did
not pass QC and QC lockout is enable.

• The Next Cal and if programmed the Next QC is displayed.

• Two fluid gauges display the approximate remaining solu­tions for the reagent cartridge and control cartridge.

3.2 Questionable Results

Results with a problem display a symbol in the Alert column. 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 than the defined reference range for the parameter.

• ↑↑ (double up arrow), ↓↓ (double down arrow) - The result is higher

or lower than 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 X 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.

3.3 System Status Screen

This screen only appears if there are operational messages or status
codes.

3-1

3 Operational Status Stat Profile pHOx Training Manual

NOTES:

3-2

4 Calibrating the Analyzer Stat Profile pHOx Training Manual

NOTES:

4 Calibrating the Analyzer

4.1 Full 2-Point Calibration - all except Hb and

• Uses internal calibrators (standards)

• Calculates slopes for sensors and air detectors

• Occurs at regular intervals or can be manually initiated by
pressing Calibrate (soft key)

• Included as part of most maintenance routines

• Resets calibration timers

• Can generally be stopped by pressing Exit (soft key)

• Can be manually run by pressing the Calibration (soft key)
from the Ready (or Not Ready) screen.

1. The 2 pt. Calibration screen will display.

2. Select option 1: pH, PCO2, PO2, Hct Calibration (ABG).

3. Press Enter.

4.2 Calibration Timing

Auto calibration takes place at intervals of 2, 4, or 6 hours depending
on analyzer activity. See Chapter 3 of the Reference Manual for more
details.

S

O

2

4-1

4 Calibrating the Analyzer Stat Profile pHOx Training Manual

NOTES:

4.3 Other Types of Calibration

4.3.1SO2 and Hb Calibration

• Uses external calibrators (2 levels)

• Initiated by the operator monthly or as needed

• Access from Ready screen: Calibrate (soft key)

Instructor shows
Calibration
Configuration screen
for calibration options.
Access the Setup
Menu (Password),
select Operation
Configuration Menu
(press Enter). Select
the Calibration
Configuration option
(press Enter). Discuss
the options.

CLIA regs. require 30
minutes.

4.3.2 Single Point Calibration for Non-Gas Sensors

• Values for calibration (standards) are lot specific and must
be verified or reentered at time of calibration.

S

O

See Calibrating

• Occurs with each gas Cal I (30-45 min. intervals) if Mode A
is selected

• Occurs with each analysis if Mode B is selected

• Uses a calibration standard (either C or A) and increases
time to appearance of results

• Checks for sensor drift

• Printing of drift is operator selected.

and Hb Checklist.

2

Mode A: One point
fluid & Gas Cal done
every 30-45 minutes.

Mode B: One point fluid
& Gas Cal done with
EACH analysis.

4-2

4 Calibrating the Analyzer Stat Profile pHOx Training Manual

Calibrating SO2 Checklist

NOTES:

Step 1 Begin calibration.

• From the Home (Ready) screen, press Calibrate (soft key).

• Then select option 2: External two standard Hb,
Calibration then press ENTER.

• The External Standard Hb, SO2% Calibration screen ap­pears.

SO

%

2

Step 2 Verify calibrator (standard) values.

• Consult insert sheet for this lot and compare to values on the
screen.

• Key in the assay value for Std. #1, if necessary.

Step 3 Prepare calibrator #1.

• Mix gently by inversion.

• Open the ampule carefully to avoid injury (glass edges).

• Position Calibrator #1 so that the extended probe tip is well
covered by the solution.

• Press Continue (soft key).

• When system signals by audible alarm, remove the ampule,

• Press Analyze (soft key).

Step 4 Prepare calibrator #2.

• Repeat procedure for calibrator #2.

• Enter/verify assay value for Std. #2. (Press ENTER after
entering the assay value.)

• Mix gently by inversion.

• Open the ampule carefully to avoid injury (glass edges).

• Position Calibrator #2 so that the extended probe tip is well
covered by the solution.

• Press Continue (soft key).

• When system signals by audible alarm, remove the ampule,

• Press Analyze (soft key).

4-3

4 Calibrating the Analyzer Stat Profile pHOx Training Manual

NOTES:

4-4

5 Using and Handling Controls Stat Profile pHOx Training Manual

NOTES:

5 Using and Handling Controls

5.1 Controls

CAUTION:

of controls other than Nova controls and will void warranty on
components that come into contact with them.

The Stat Profile pHOx Analyzer has on board QC and on board
controls. Controls can be analyzed either with the internal control
pack or with external Nova control ampules.

Performance of the analyzer may be affected by the use

5.1.1 Stat Profile pHOx Controls

• Monitor performance of all blood gases and electrolytes

• Contain no preservatives, dyes, or surfactants that can
damage sensors or other flow components

• Formulated at 3 clinically significant levels:
L1 Acidosis, with low pH, high PCO2, low PO2, low SO2,

low normal Hct and low normal Hb values

L2 Normal, with normal pH, PCO2 and PO2 values
L3 Alkalosis, with high pH, low PCO2, high PO2 high

SO

, and normal high Hct/Hb values

2

• Internal in a self-containing control pack (Auto- Cartridge
QC) or external in individual ampules

The Auto- Cartridge

QC has a use-life of 35

days.

5.2 Handling Controls

5.2.1 Storage Temperature

Store at 25°C (77°F). Warmer or colder controls affect gases and pH.
Hold vial between thumb and fingertip when shaking to avoid
changing temperature. For every 1°C
1%. The opposite effect is seen at temperatures

CAUTION:

sill or near a heating or air-conditioned duct.

Do not refrigerate. Avoid storing controls on a window

above

25°C, PO2 recovery drops

below

25°C.

5-1

5 Using and Handling Controls Stat Profile pHOx Training Manual

NOTES:

5.2.2 Stability of Opened Ampules

Shake and analyze within 30 seconds of opening. Contamination with
room air will begin to affect PO2, PCO2, and pH results after that time.

PO

Room air has a
Exposure of controls to room air causes:

PCO

to decrease.

2

5.2.3 Altitude and Barometric Pressure Effects

Aqueous controls are assayed at sea level. Changes in altitude will affect
gas recovery. For every 1000 ft above sea level, PO2 recovery drops by
approximately 0.5%. An incorrect barometric pressure will also affect
gas recovery. System barometric pressure is displayed on the printout,
barometric pressure, or Status screen. If significantly different from a
known, accurate measurement, enter an offset by selecting Setup, enter
password, select Operations Configuration, press Enter, select System
Configuration Menu (use arrow keys to go to corrected Barometric
Pressure), enter mmHg, Press Home to exit to Home (Ready) screen.

of about 150 mmHg and a PCO2 of ~0 mmHg.

2

PO

and pH to increase,

2

5.3 When to Use

As of the date of publication of this guide, a minimum of one blood
gas control must be analyzed every 8 hour shift of lab operation. Also,
after maintenance or troubleshooting or as required by the laboratory’s
quality control program. All levels must be analyzed within a 24 hour
period.

5.4 Using the Stat Profile pHOx's On-Board QC Features

The analyzer's QC features allow you to:

• Set ranges and units for acceptable results.

• Store statistics.

• Program for internal or external control source.

• Display or print QC statistics in the form of reports.

• Remind or require operators to run QC at specific intervals.

• Analyze other forms of QC such as proficiency surveys or
linearity standards without “offsets”.

5-2

5 Using and Handling Controls Stat Profile pHOx Training Manual

NOTES:

These features must be enabled or setup before they can be used. See
Quality Control Setup in the analyzer’s reference manual for details. If
you will be using them, the installer will have done at least a partial
setup so that you can learn how they work.

5.4.1 The QC Soft key

This key has more than one function:

• To run a QC analysis either internal or external

• To view or to print QC data

• To set up QC levels

• To turn automatic QC analysis on or off

5.4.2 Automatic QC Analysis (Internal)

To use the Automatic QC Analysis feature properly, the QC analysis
times need to be programmed under the Daily Analysis Times screen
during the QC Setup and the Automatic QC Analysis needs to be
turned on. QC is automatically performed at these programed times
with the controls from the Auto-Cartridge QC.

NOTE:

Internal QC can also be run manually: see the checklist.

5.4.3 Manual QC Analysis (External)

To use the Manual QC Analysis feature properly, the QC analysis
times need to be programmed under the Daily Analysis Times screen
during the QC Setup and the Automatic QC Analysis needs to be
turned on. When QC analysis is needed, a Pop up screen will appear
prompting you to run the required QC. Press OK (soft key). Then go
to the Analyze QC screen and select the appropriate QC.

GO TO CHECKLIST.

5-3

5 Using and Handling Controls Stat Profile pHOx Training Manual

DWG #6010A

NOTES:

Analyzing Controls Checklist

Step 1 Preparing for Analysis

• Hold QC ampule between thumb
and forefinger and agitate vigor­ously for several seconds.

NOTE:

Do not warm ampule in hands.

Step 2 Initiating the QC Analysis

• Press QC (soft key) on the Home screen.

• With Analyze QC Highlighted, press ENTER.

• Select the QC to be analyzed, i.e., QC Level #1 External.

• Change if necessary by pressing Previous Control (soft key)
or Next Control (soft key).

• Press the White Button (Syringe) or Analyze (soft key).

Step 3 Completing the Cycle

Figure 5.1 Agitating the Ampule

5-4

• Once probe has extended, open the ampule while protecting
yourself from the sharp glass edges.

• Fully immerse the probe into the fluid of the ampule. Do not
allow the probe to touch the bottom of the ampule.

• Press Continue (soft key).

• When the system signals by an audible alarm, remove the
ampule and press Analyze (soft key). The probe moves
downward.

• Discard the ampule.

NOTE:

cause the system to
to the Quality Control screen.

Failure to press Continue (soft key) within 45 seconds will

time-out

canceling the cycle and returning you

5 Using and Handling Controls Stat Profile pHOx Training Manual

Analyzing Controls Checklist

NOTES:

Step 4 Accepting or Rejecting Results

When results are ready, they appear on the screen along with
an indication of whether they have passed or failed the QC
range check. If one or more tests are out of range, the QC
Results screen flashes Exceed Limits.

• To save all data, press QC (soft key).

• To reject the data, press Delete (soft key). Then press
Continue to discard all the data.

• All data is either accepted or rejected.

Step 5 Repeat for next level

5-5

5 Using and Handling Controls Stat Profile pHOx Training Manual

NOTES:

Analyzing Internal Controls Checklist

Step 1 Preparing for Analysis

• From the Ready screen, press QC (soft key) on the Home
screen.

Step 2 Initiating the QC Analysis

• With Analyze QC Highlighted, press ENTER.

• Select the QC to be analyzed, i.e., QC Select Internal L1.

• Change if necessary by pressing Previous Control (soft key)
or Next Control (soft key).

• Press Analyze (soft key).

Step 3 Accepting or Rejecting Results

When results are ready, they appear on the screen along with
an indication of whether they have passed or failed the QC
range check. If one or more tests are out of range, the QC
Results screen flashes Exceed Limits.

• To save all data, press QC (soft key).

• To reject the data, press Delete (soft key). A pop-up screen
appears: enter your password. Then press Continue to dis­card all the data.

• All data is either accepted or rejected.

Step 4 Repeat for next level

5-6

5 Using and Handling Controls Stat Profile pHOx Training Manual

NOTES:

5.5 QC Data

To view QC data, select View or Print QC Data on the Quality Control
(QC) screen then press Enter. The QC Data screen for the selected
level is displayed. From this screen, you can view today's data, daily
statistics, monthly statistics, cumulative, or Levey-Jennings.

5.5.1 View Today's Data

From the QC Data screen, select View Today's Data then press Enter.
The QC Results screen is displayed. To view the next result, press
Next Page (soft key). For options, press Options (soft key). A pop-up
window appears. One option is for deleting this result. You can also
print or view other statistics.

5.5.2 View Daily Statistics

From the QC Data screen, select View Daily Statistics then press
Enter. This screen is the QC Daily Statistics for the selected level.
From this screen, you can view the next level, and/or print the
statistics.

5-7

5 Using and Handling Controls Stat Profile pHOx Training Manual

NOTES:

5.5.3 View Monthly Statistics

The Monthly Statistics is a record of all QC accepted for the past month.
Print this record for your files at the end of each calendar month.

1. From the Quality Control screen, select View or Print QC Data.

2. From the QC Data screen select View monthly statistics.

3. Press Print (soft key).

=======Stat profile QC Statistics======

Date 6-23-98 Time 10:54
Analyzer ID 0 Operator ID 1
Lot#1234567890 Exp 7-31-98

----------------------------------------------------

DAILY (n=6)

Test Mean ±Range SD CV

pH 7.595 0.050 2.3 2.3
pCO223.0 10.0 2.3 2.3
pO
SO
Hb 7.5 10.0 3.5 3.5
Hct 18 10.0 2.3 2.3

----------------------------------------------------

Test Mean ±Range SD CV

pH 7.595 0.050 2.3 2.3
pCO223.0 10.0 2.3 2.3
pO
SO
Hb 7.5 10.0 3.5 3.5
Hct 18 10.0 2.3 2.3

----------------------------------------------------

QC CUMULATIVE (n=1,498 during163 days)

Test Mean ±Range SD CV

pH 7.595 0.050 2.3 2.3
pCO223.0 10.0 2.3 2.3
pO
SO
Hb 7.5 10.0 3.5 3.5
Hct 18 10.0 2.3 2.3

----------------------------------------------------

155 12.0 1.0 1.0

2

.... .... .... ....

2

MONTHLY (n=97 during 30 days)

155 12.0 1.0 1.0

2

.... .... .... ....

2

155 12.0 1.0 1.0

2

.... .... .... ....

2

5-8

Figure 5.2 QC Statistics Printout

5 Using and Handling Controls Stat Profile pHOx Training Manual

NOTES:

5.5.4 Printing Levey-Jennings Charts

The Levey-Jennings data graph is displayed on screen. When print­ing, each graph will be rotated 90° with the date appearing on the long
axis of the chart.

1. From the Quality Control screen, select View or Print QC Data.

2. From the QC Data screen, select View Levey-Jennings.

3. Highlight the analyte using the arrow key.

4. Press enter to view data on the screen.

5. Press Print (soft key).

=======Stat profile QC Statistics======

LEVEY-JENNINGS CHARTS
Analyzer ID 0 Operator ID ...
Lot # 1234567890 Exp Date 07-31-98
Date Lower Limit Upper Limit

----------------------------------------------------

7.585 7.600 7.635

---------------------------------------------------­11-23 *
11-24 *
11-25 *
11-26 *
11-27 *
11-28 *
11-29 *
11-30 *
12-01 *
12-02 *

Figure 5.3 Levey-Jennings Graphs Printout

5-9

5 Using and Handling Controls Stat Profile pHOx Training Manual

NOTES:

5-10

6 Replacing Reagents & Paper Stat Profile pHOx Training Manual

NOTES:

6 Replacing Reagents and Paper

6.1 When to Replace

Replace the fluid pack and/or the control pack when it has reached its
expiration date or when the graphic appears empty on the Home
screen. Also, replace the capillary adapter found in the reagent pack.

6.2 How to Replace

To install a new reagent pack and/or control pack, you will be using one
of the automated Operational Menu procedures: Change Reagent Pack
or Change Control Pack. These procedures come up as screens with
the steps necessary to carry out the changing of the pack. Because the
reminders are brief, you should refer to the complete illustrated proce­dures located in the maintenance section of the analyzer's reference
manual if you need additional details. To stop automated maintenance
procedures, press Cancel (soft key).

The on-board Reagent

Cartridge has a use-

life of 45 days.

The on-board QC

Cartridge has a use-

life of 35 days.

6.3 Replacing the Reagent Pack

See Replacing the Reagent Pack Checklist to perform the lab.

6.4 Replacing the Control Pack

See Replacing the Control Pack Checklist to perform the lab.

6.5 Replacing the Printer Paper

See Replacing the Printer Paper Checklist.

6-1

6 Replacing Reagents & Paper Stat Profile pHOx Training Manual

NOTES:

Replacing the Reagent Pack/Capillary Adapter Checklist

WARNING: Blood samples and blood products are potential sources of
hepatitis and other infectious agents. Handle all blood products and
flow path components (waste-line, septum assembly, probe, flow cell,
etc.) with care. Gloves and protective clothing are recommended.
Dispose of the reagent waste bottle according to your laboratory's
biohazardous waste policies.

Step 1 Replace the capillary adapter.

• From the Home (Ready) screen, press Menu.

• Select Change Pack.

• Press Enter. A pop-up screen appears.
Change Reagent Pack

Change Control Pack
Exit

• Highlight Reagent Pack.

• Press Enter.

• Press Move Probe (soft key).

• Open the door.

• Remove the capillary adapter from the front of the probe by

pulling it off.

• Replace the adapter with a new one found in the reagent

pack. As you put on the adapter, make sure the probe goes
into the center hole of the adapter.

• Press Move Probe (soft key) when finished.

• Press Cancel then press Cancel again to return to the Home

screen.

6-2

Step 2 Remove old cartridge.

• Open the door.

• Remove the old cartridge - lift the cartridge up slightly to

clear the lip.

• Mix the new cartridge by gently inverting for several seconds.

DO NOT SHAKE THE PACK.

• Slide in the new cartridge.

• Close the door.

Update to PN 24302 Rev. B 3/2002

6 Replacing Reagents & Paper Stat Profile pHOx Training ManualReplacing the Reagent Pack/Capillary Adapter Checklist

Step 3 Prime the analyzer.

• Press Prime (soft key): this primes and validates the car­tridge.

Step 4 Calibrate the analyzer.

• After priming, a pop-up screen appears with a question, "Do
you want to recalibrate? Yes or No." Press Yes (soft key).

• Calibration takes place.

Step 5 Validate performance with QC.

• Run QC.

• Document the results.

NOTES:

6-3

6 Replacing Reagents & Paper Stat Profile pHOx Training Manual

NOTES:

Replacing the Control Pack Checklist

WARNING: Blood samples and blood products are potential sources of
hepatitis and other infectious agents. Handle all blood products and
flow path components (waste-line, septum assembly, probe, flow cell,
etc.) with care. Gloves and protective clothing are recommended.
Dispose of the reagent waste bottle according to your laboratory's
biohazardous waste policies.

Step 1 Initiate the procedure

• From the Home (Ready) screen, press Menu.

• Select Change Pack.

• Press enter. A pop-up screen appears.
Change Reagent Pack

Change Control Pack
Exit

• Highlight Control Pack by using the down arrow key.

• Press Enter.

Step 2 Follow the screen directions.

• Open the cover.

• Remove the old cartridge - lift the cartridge up slightly to

clear the lip.

• Mix the new cartridge by gently inverting for several seconds.

DO NOT SHAKE THE PACK.

• Slide in the new cartridge.

• Close the door.

Step 3 Prime the analyzer.

• Press Prime (soft key).

Step 4 Calibrate the analyzer.

• After priming, a pop-up screen appears with a question, "Do

you want to recalibrate? Yes or No." Press Yes (soft key).

• Calibration takes place.

6-4

Step 5 Validate performance with QC.

• Run QC.

• Document the results.

Update to PN 24302 Rev. B 3/2002

6 Replacing Reagents & Paper Stat Profile pHOx Training Manual

Replacement of the Printer Paper Checklist

NOTES:

Step 1 Open the printer cover.

Step 2 Lift print head.

• Open the printer platen.

• Gently pull the lever near the paper advance knob forward.

• Remove the depleted roll of paper.

Step 3 Remove paper holder from the old roll of paper.

Step 4 Install new roll of paper.

• Insert the paper holder into
a new roll of paper. The
loose end of the paper
should feed from the bot­tom of the roll.

• Install the paper holder with
paper into the support col­lars.

• Push the paper through the
back of the roller.

Step 5 Reposition print head.

DWG #10-1002B

Platen



Paper Advance

Knob

Figure 6.1 Paper Installation

• Center the paper and close the printer platen by moving the
lever back to the original position.

• Advance the paper by using the paper advance knob.

• Feed the paper through the cover. Then close the cover.

6-5

6 Replacing Reagents & Paper Stat Profile pHOx Training Manual

Replacement of the Printer Paper Checklist

NOTES:

Step 6 Test printer (Optional).

• From the Home screen, press Menu (soft key); press Service
(soft key); use the down arrow key to select Printer Menu:
press ENTER; use the down arrow key to select Character
Set Test; finally press ENTER to obtain a character printout
to verify proper operation (see Figure 6.2).

• After the self test is completed, a pop-up screen appears.
Press OK.

• Press Home (soft key) to return to the Home screen

** TEST PRINT **
!”#$%&’()*+,-./01234567
89:;<=>?@ABCDEFGHIJKLMNO
PQRSTUVWXYZ[\]
hijklmnopqrstuvwxyz{|}~

^

‘abcdefg

—

ЗьйвдаезклипомДЕ
ЙжЖфцтыщяЦЬ¢£¥ ƒбнуъсСao

1

¿

αβΓπΣσµτΦθΩδ∞φ∈
≡±≥≤ ÷≈°.−

DWG #9-1000A

1

〈〈 〉〉

/

/

2

4

n2

§ßØø °

Figure 6.2 Sample Test Printout

¨

6-6

7 Troubleshooting Stat Profile pHOx Training Manual

NOTES:

7 Troubleshooting

Instructor: Show

these screens as they

7.1 Sensor Screens

For a full description of these screens, turn to Chapter 6 of the Reference
Manual.

From the Home screen, press Menu (soft key). Then press Service
(soft key). Using the down arrow key, select Sensor Subsystem. Then
press ENTER.
Calibration and analysis data for each sensor, the SO2 LEDs, and the
air detectors are contained on the following screens.

7.2 System Test

For a full description of this screen, turn to Chapter 6 of the Reference
Manual.

From the Home screen, press Menu (soft key). Then press Service
(soft key). Using the down arrow key, select System Test then press
ENTER.
The System Test screen displays millivolt readings for all sensors.
From this screen, you can manipulate the pHOx Plus to perform many
actions, i.e., priming. It also allows you to check the sampler, rotary
valve, pump, waste valve, reference valve, ADTs, and SO2 LEDs.
Turn to Chapter 6 of the Reference Manual for procedures on how to
perform these tests.
The operator flow test is performed from the System Test screen by
pressing Operator Flow Test (soft key). The pump turns on, the probe
moves to the syringe position, and the waste valve opens. This allows
the user to present a cup of water to the probe and observe the flow of
water.

are discussed.

7-1

7 Troubleshooting Stat Profile pHOx Training Manual

NOTES:

7.3 Error Log

From the Home screen, press Menu (soft key). Then press Service
(soft key). Using the down arrow key, select Error Log and press
ENTER.
This screen shows all errors displayed in chronological order fol­lowed by a short explanatory message - holds 96 errors.
For more detailed information, refer to the Reference Manual (Chapter 5,

Troubleshooting).

An index lists all the status messages by code with a symptom and
corrective action.

7.4 Flow Related Problems

The cause of flow problems are clots, hidden blockages, leaks, and
pumping problems.
The errors show up as flow status codes. Resolve by referring to
solutions described in the Reference Manual, Troubleshooting chapter, for
that status code.

NOTE:

Always fix flow problems first.

Flow problems are often accompanied by sensor related problems. Do
not change sensors or membranes until flow problems have been
resolved. Once flow problems are resolved, sensor problems often
disappear.
Diagnose with flow tests: Water Test, Pump Test, and Reference
Solution Test.

Water Test — Checks to verify that water can be pulled
through the system from the probe. If water cannot be
aspirated through the probe, a clog, leak, or a mechanical
pump problem exists in the system.

Pump Test — Checks to verify that the pump and waste valve
are functioning properly. Also verifies if the W-line from
the reference electrode to the waste bottle is free of block­ages.

Reference Solution Test — Verifies reference solution is get­ting to the reference electrode.

7-2

7 Troubleshooting Stat Profile pHOx Training Manual

NOTES:

7.5 Sensor Problems

Problems may be uncalibrated, overload, instability, slope, drift, out
of range, and dependency status codes.
Resolve by referring to solutions described in the Chapter 5, Trouble-

shooting, in the Reference Manual for that status code.

7.6 Results Related Problems

Problems may occur because sample results are either too high or too
low. Can be combination of two or more results problems.
See Resolving Results Problems in the Quick Reference section.
Resolve by referring to solutions described in the Chapter 5, Trouble-

shooting, in the Reference Manual for that error code.

7.7 Miscellaneous Problems - Operational

Problems may be related to lab temperature, incorrect barometric
pressure, open door, or reagent pack problems.
Resolve problems by lowering/raising temperature, correcting baro­metric pressure in the analyzer, closing door, and reinstalling/install­ing a new reagent pack.

7.8 Call Nova

For problems involving hardware, electronics, printer, or software
error messages.
Problems that cannot be resolved by you or at your site.
Resolve problems by calling Nova Technical Services at
1-800-545-NOVA. Have the serial number and the closest phone
extension to the instrument ready.

7-3

7 Troubleshooting Stat Profile pHOx Training Manual

NOTES:

7-4

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

8 Flow Test and Flushing

8.1 Manual Flow Test Lab

WARNING: Use appropriate protective face shield, gloves, etc., when
attempting to flush, clean or handle any components of the analyzer which
come in contact with blood specimens.

The Stat Profile pHOx flow tests are used to troubleshoot fluidic
problems that might give the following status codes:

• 71 Flow - No Std A

• 72 Flow - No Std B

• 73 Flow - No Std C

• 74 Flow - No Std D

• 75 Flow - Flow long/short

• 76 Flow - No sample

• 77 Flow - No air

The fluid system can be isolated into 3 large sections:

• Fluid Pack to fluid fountain

• Sampler/sensor module

• W/R-lines to waste tubing

Performing the flow test limits the search to one of the fluid sections.

What you will need to do this test:

1. A sample cup, 25 mL medicine cup, or 25 mL beaker

2. Deionized water

3. Syringe with blunt needle and silicone tubing (probe cleaning
kit or equivalent)

4. Lint-free tissue or gauze

8-1

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

From Ready→Service→System Test→Customer Flow Test

Operator Flow Test

1. - Lift the tubing out of the Waste solenoid.

1

- If tubing remains pinched, roll it between fingers to loosen.

- Place the sample probe in a cup of water.

1

2

Is fluid flow noticed in the waste line tubing?

A. IF YES, call your Nova Service Representative.
B. IF NO, go to Step 2.

2. - Disconnect the Waste (W) from the Reference Electrode.

2

- Place this end of the W tubing into a cup of water.
Is fluid flow seen in the Waste line tubing?

A. IF YES, press “PUMP” to turn off the pump motor.

Go to the next page,

“Sensor Module Back Flush” procedure.

B. IF NO, go to Step 3.

3. - Disconnect the Waste line tubing from the front panel port.

3

- Place this end of the tubing over a gauze to prevent spilling.

- Aspirate water from the same location as in Step 2 above.

Is fluid seen exiting the Waste tubing end you just disconnected?

A. IF YES, go to Step 4.
B. IF NO, Replace the W/R Tubing Harness ( P/N 23023)

4. - Press the “PUMP” key to stop the Pump Motor

4

- Remove the Reagents Cartridge from the unit.

- Install the flush adapter.

- Place the flush adapter tubes into an empty beaker.

- Inject water to the front panel Waste port.

- Water should flow through the adapter waste tube.
(Adapter waste line is last to the right)

* Loss of Reference flow will change the flow rate.

Reference solution will flow at a rate of 1 -2 drops/second
during a pumping cycle.

** If this tubing cannot be flushed call your Nova Service
Representative. If tubing flushes easily, change the Reagents

Cartridge. In a small number of cases the original problem
may have been poor alignment of the Reagents Cartridge.

8-2

4

3

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

Sensor Module Back Flush Procedure

5. If you are starting from the Operator Flow Test

5

-Turn the Pump OFF by pressing the “PUMP” key.

6. If you are starting from the Ready Screen

7

8

6

- Press Service, System Test and select the Operator Flow Test.

- Turn the pump OFF as in Step 5.

7. Connect a syringe filled with water to the Reference

7

electrode waste port.

8

4. Back flush the flow path by injecting the water.
Caution: Place a gauze or towel at the sample probe tip to
receive the obstruction or water.

9. If the water easily flushes through the sensor module,

9

you may have an air leak into the flowpath. This will be
from an interconnect tubing, failed membrane, or poorly
seated electrode. Go t o Step 15.

10

6. If water does NOT exit the sample probe.

10

- Lift the Reference electrode off the sensor module.

- Flush the Reference electrode.

11

If it flows freely, confirm that the interconnect tubing is
properly positioned and reinstall the Reference Electrode.

13

14

7. Disconnect the Air Detector from the bottom of Sensor

11

Module.

8. Inject water into the W port of the Reference Electrode.

12

Does water flow through the sensor module?
IF YES, go to Step 13.
IF NO, go to Step 14.

9. - Connect the syringe to the Sample Probe tip.

13

- Inject water through the Probe
Water should exit the Air Detector (ADT) tubing.
IF NO flow is noted, flush the ADT and probe separately.
IF the water flows easily, the seal between the ADT and
probe may be leaking. Replace the Air Detector.

(NO from Step 12) The obstruction lies in the flowcell.

14

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

( From Step 9) Connect the syringe with water to the

15

sample probe tip. Reconnect the Reference electrode
Waste line. Apply a slight pressure to the syringe. Look
for water entering a flowcell, electrode cap, or leaking
from the interconnect tubing. Replace the membrane, or
tubing as required.

15

If the above does not identify the problem,
please contact your Nova Service Representative.

8-3

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

8.1.1 Water (Flow) Test

The water (flow) test verifies that fluid can be pulled through the
system from the probe. If water cannot be pulled through the system,
a clog, leak, or mechanical pump problem exists.

1. From the Home screen, press Menu (soft key)

2. Press Service (soft key).

3. From the Service screen, select System Test. Then press
Enter.

4. Move the sampler to the syringe position by using the arrow
keys at the bottom right corner of the key pad.

a. Select Sampler.
b. Press Enter.
c. Select Syringe.
d. Press Enter.

5. Open the waste valve by using the arrow keys at the bottom
right corner of the keypad.

a. Select waste valve
b. Press Enter. (Valve toggles to open position if

closed.)

6. Turn the pump on to fast speed by using the arrow keys at the
bottom right corner of the key pad.

a. Select Pump.
b. Press Enter.
c. Select Fast.
d. Press Enter.

7. Fill a 2 mL sample cup with water.

8. Open the door.

9. Insert the probe into the cup of water and observe for water
being aspirated.

8-4

If water is NOT aspirated from the cup, then go to the Pump Test to
check waste aspiration.
If water is aspirated from the cup, then the sample probe, sensor
module, external tubing, and waste line are functioning with no
blockage. The problem exists between the reagent pack and fluid
fountain. Call Nova Service.

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

8.1.2 Pump Test

The pump test verifies that the pump is working properly and is
capable of providing suction to the sensor module and probe.
If already on the System Test screen, skip to Step 4., otherwise, start
with Step 1 below.

1. From the Home Screen, press Menu (soft Key)

2. Press Service (soft key).

3. From the Service screen, select System Test. Then press
Enter.

4. Move the sampler to the syringe position by using the arrow
keys at the bottom right corner of the keypad.

a. Select Sampler.
b. Press Enter.
c. Select Syringe.
d. Press Enter.

5. Open the waste valve by using the arrow keys at the bottom
right corner of the keypad.

a. Select Waste Valve.
b. Press Enter. (Valve toggles to open position if

closed.)

6. Turn pump to fast speed by using the arrow keys at the
bottom right corner of the key pad.

a. Select Pump.
b. Press Enter.
c. Select Fast.
d. Press Enter.

7. To check the W-line for aspiration, fill a 2 mL sample cup
with water.

8. Remove the tubing from the waste port of the reference
electrode and place the waste tubing in the cup of water.

9. Observe for water being aspirated.

If water is aspirated during the pump test and not in the water (flow)
test, there is a blockage or leak between the reference electrode, the
sensor module, air detector, and probe. Proceed to the Flow Path
Flush Procedure.
If water is not aspirated during the pump test, the problem is with the
W-line, waste valve, pump, or waste bag. Proceed to Step 10 below.

8-5

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

10. If water is not aspirated, lift the waste tubing out of the waste
valve. If flow starts, the tubing may have been collapsed or
pinched, or the waste valve may be dirty or not working.
Correct the problem. (Clean, if necessary, or call Nova
service)

11. If flow does not start, remove the waste line from the front
panel connection below the pump. Be ready to catch any
water that is expelled from the tubing.
If water flows from this tube there is a plug in the internal
waste tubing or waste bag of the reagent pack.

12. Turn off the pump by using the arrow keys at the bottom
right corner of the keypad.

a. Select the Pump.
b. Press Enter.
c. Select Stop.
d. Press Enter.

13. Connect a syringe (Probe Cleaning Syringe PN 02702)
filled with water, that has a length of tubing attached, to the
waste port on the front panel. Attempt to inject water
through the line to clear the plug.

14. If there is not flow, remove the reagent pack to ensure the
problem is not a poorly seated or damaged waste connec­tion. Should the problem continue call Nova Service.

15. If the problem is resolved, reconnect the correct ends of the
W-line to the waste port on the front panel and on the waste
port of the reference electrode.
Also position the tubing back into the waste valve.

16. Rerun the water test to verify proper flow.

8-6

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

8.1.3 Flushing Sensor Module, Air Detector, and Probe

If already on the system test screen, skip to Step 4, otherwise, start
with Step 1 Below.

1. From the Home Screen, press menu (soft Key)

2. Press Service (soft key).

3. From the Service screen, select System Test. Then press
Enter.

4. Move the sampler to the syringe position, if not already
there, by using the arrow keys at the bottom right corner of
the keypad.

a. Select Sampler.
b. Press Enter.
c. Select Syringe.
d. Press Enter.

5. Remove the W-line tubing from the waste port of the
reference electrode.

6. Connect a syringe (Probe Cleaning Kit PN 02702) filled
with water, that has a length of tubing attached, to the waste
port of the reference electrode (see Figure 8.1).

NOTE:

The probe should still be in the syringe position.

WARNING:

Water may spray out of the probe.

7. Gently push the water through the reference electrode, sensor
module, air detector, and probe. If the flow path is clear, the
plunger can be depressed with no resistance, otherwise, resis­tance will be felt. The blockage may be dislodged by pushing
the water through the flow path. If not, flush the suspected
individual components by proceeding to the Flushing the
Reference Electrode procedure (Section 5.5.4).

8. When the blockage is cleared, a nice steady stream of water
should be seen coming out of the probe.

9. Rerun the water test to verify proper flow. The Sampler
should be in the syringe position.

a. Turn pump to fast speed.
b. Open waste valve.
c. Insert the probe into a cup of water and observe for

water being aspirated.
If water flowed freely during the flush procedure but still
does not pass the water test, then air is entering the system
preventing aspiration.

8-7

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

a. Verify interconnect tubing is properly connected.

Reseat if necessary.

b. Inspect the seal between the reference electrode

and sensor module. Replace interconnect tubing,
if necessary.

c. Inspect each sensor to assure internal fill solution

is at the proper level. If not replace cap.

d. Inspect pH sensor to assure glass tip is not broken.

Replace sensor, if necessary

10. Rerun the water test.

11. Once proper flow has been established, turn the pump off.
Use the arrow keys at the bottom right corner of the keypad.

a. Select pump.
b. Press Enter.
c. Select Stop.
d. Press Enter.

12. Move the sampler back to the Home position. Use the arrow
keys at the bottom right corner of the keypad.

a. Select Sampler.
b. Press Enter.
c. Select Home.
d. Press Enter.

13. Close the waste valve by using the arrow keys at the bottom
right corner of the keypad.

a. Select waste valve.
b. Press Enter (valve toggles to closed position if

open).

14. Press Home (soft key).

8-8

8.1.4 Flushing the Reference Electrode

1. Remove the W-line and R-line from the reference electrode.

2. Lift the reference electrode off the sensor module by pulling
up on the locking pin that is on the top of the reference
electrode.

3. Connect a syringe (Probe Cleaning Syringe PN 02702)
filled with water, that has a length of tubing attached to it, to
the W-port of the reference electrode. While covering the R­port with your finger, push water through the electrode so
that the water flows out of the flow cell port. Repeat by
attaching the syringe to the R-port and covering the W-port
while pushing water through the electrode.

4. Reinstall the reference electrode.

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

8.2 Flushing the Entire Flow Path

Flush flow path when a flow problem has been detected. Typical flow
problem error codes are Insufficient Sample, No Std A, B, C, or D
Fluid.
Flush individual components only if the problem is not cleared by a
flow path flush.

WARNING:

Use appro­priate protective face
shields, gloves, etc.,
when attempting to
flush, clean, or handle
any components of the
analyzer which come
in contact with blood
specimens.

DWG #10-1025A

Figure 8.1 Flow Path Air Flush

8-9

8 Flow Test & Flushing Stat Profile pHOx Training ManualFlushing the Flow Path Checklist

NOTES:

WARNING:

when attempting to flush, clean, or handle any components of
the analyzer which come in contact with blood specimens.

Step 1 Initiate Flowpath maintenance.

• Press Menu (soft key) on the Home screen.

• The Operational Menu screen appears.

• Select Service Menu (soft key); enter password, if enabled.

• Select System Test. Press Enter.

• Select Sampler by moving the cursor with the arrow keys.

• Select syringe by moving the cursor with the arrow keys.

• Open the door.

Use appropriate protective face shields, gloves, etc.,

Then press Enter.

Then press Enter.

Step 2 Prepare syringe.

• Disconnect the W-line from the side of the reference elec­trode.

• Attach a length of tubing to the end of the Probe Cleaning
Syringe (PN 02702).

• Pull back the plunger of the syringe to fill it with air.

• Attach the syringe tubing to the W-line port. (Refer to Figure

8.1, if necessary.)

Step 3 Flush air through flow path.

• Press syringe plunger in slowly. If flow path is clear, the
plunger can be depressed with no resistance. If a clot or other
obstruction is present, resistance will be felt. If necessary,
repeat the procedure using deionized or distilled water.

8-10

8 Flow Test & Flushing Stat Profile pHOx Training Manual

Flushing the Flow Path Checklist

NOTES:

Step 4 Determine results.

• Continue to Step 5 if the obstruction has been flushed free.

• If not, repeat flush procedure using deionized or distilled

water or contact key operator of lab for assistance.

Step 5 End flush procedure if no other components need

flushing.

• Remove syringe.

• Reattach the W-line to the reference electrode.

• Press Exit (soft key) to return to the home position.

• Close the door.

• Press Home (soft key) twice to return to Home screen.

Step 6 Prime the flow path.

• From the Home screen, press Menu (soft key).

• Select Flowpath/Probe maintenance. Then press Enter.

• Press Continue (soft key) to prime the flow path.

Step 7 Calibrate.

• A pop-up screen appears to question - Do you want to
recalibrate? Yes or No.

• Press Yes; calibration takes place.

NOTE:

screen, press Calibrate (soft key) to recalibrate analyzer.

If No is pressed, you can still recalibrate. From the Home

• Contact key operator (or lab) for assistance if problem is not
resolved.

8-11

8 Flow Test & Flushing Stat Profile pHOx Training Manual

NOTES:

8.3 Reference Solution Test

1. Press Menu (soft key) on the Home screen.

2. The Operational Menu screen appears.

3. Select Service Menu (soft key); enter password, if enabled.

4. Select System Test. Press Enter.

5. Using the arrow keys, highlight Ref Valve.

6. Press Enter to toggle from Closed to Open.

7. Using the arrow keys, highlight Pump.

8. Press Enter and select Fast using the arrow keys.

9. Press Enter.

10. Open the door and disconnect the R-tubing from the refer­ence electrode.

11. Hold the R-tubing over a piece of gauze or sample cup to
catch any solution that may flow out of the tubing.

12. Reference solution should flow at a minimum of 1 drop per
second.

13. If there is flow, turn off the pump.
If there is no reference solution dripping out of the tubing,
verify there is reference solution or a blockage. Check for
blockage in the reference tubing or the pump harness tubing.
If necessary, replace the reagent pack.

8-12

9 Maintenance Stat Profile pHOx Training Manual

NOTES:

9 Maintenance

9.1 Logging Maintenance

The Stat Profile pHOx Maintenance Log (PN 22362) contains each of
the following types of log sheets — maintenance, quality control, and
service record.

9.1.1 Maintenance Log Sheets

Allows the operator to record the daily and preventive maintenance
procedures. A sample is shown.

9-1

9 Maintenance Stat Profile pHOx Training Manual

GOLECNANETNIAM

_____________________#rezylanA____________raeY/htnoM

123456789 01112131415161

dedeensa)40721NP(retaeherPelpmaSezinietorpeD

ylkeeWsevlaVhcniPnignibuTnoitisopeR

rehtO

GOLATADECNAMROFREP

123456789 01112131415161

:ylkeeWsepolSedortcelEdroceR

Hp

P

OC

2

P

O

2

aN

+

S

O

2

tcH

MAINTENANCE LOG

Month/Year____________ Analyzer #_______________________

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Deproteinize Probe/Sensor Module (Use PN 12704) as needed

Reposition Tubing in Pinch Valves Weekly

Clean the

S

O

2

Sensor Every 3 Months

Initial and Date When Done. Tech's Initial's_______ Date_______

Change the Pump Tubing Every 3 Months

Initial and Date When Done. Tech's Initial's_______ Date_______

Change the R-Line and W-Line Every 3 Months

Initial and Date When Done. Tech's Initial's_______ Date_______

Other

PERFORMANCE DATA LOG

17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Record Electrode Slopes Weekly:

pH

P

CO

2

P

O

2

Na

+

S

O

2

(LED1)

Hct

NOTES:

Figure 9.1 Maintenance Schedule and Performance Data Log

9-2

9 Maintenance Stat Profile pHOx Training Manual

GOLLORTNOCYTILAUQ

slortnoC

egnaRyassAyaD 123456789 01112131415161

woLnaeMhgiH

Hp

06722NP1leveL

P

OC

2

_____________#toL

P

O

2

_________etaD.pxE

S

O

2

tcH

bH

16722NP2leveL

Hp

_____________#toL

P

OC

2

_________etaD.pxE

P

O

2

Hp

26722NP3leveL

P

OC

2

_____________#toL

P

O

2

_________etaD.pxE

S

O

2

tcH

bH

SLAITINIS'NAICINHCET

NOTES:

Figure 9.2 Quality Control Log

9-3

9 Maintenance Stat Profile pHOx Training Manual

NOTES:

SERVICE RECORD

NOTE: Record serial/lot number of components

Date Nature of Problem Resolution/Comments

9-4

Figure 9.3 Service Record

10 Routine Maintenance Stat Profile pHOx Training Manual

NOTES:

10 Routine Maintenance

10.1 Overview

How often maintenance procedures are done is in part dependent on
how much the instrument is in use.
Each schedule includes daily, weekly, monthly, every 3 months, and
annual procedures.
The Stat Profile pHOx Maintenance Log helps you remember when to do
each procedure. It contains the daily and preventative maintenance
log sheets, quality control log sheets, and service record log sheets.

NOTE:

Make sure to use the correct maintenance log sheet. The

maintenance log sheets list procedures due for each month.

10.2 General Maintenance Procedures

See the Maintenance Planner (Quick Reference) for daily, weekly,
monthly, quarterly, and annual procedures.
Changes in the timing of these procedures should be made according
to the number of samples per day, the quality of the samples, and the
lab circumstances encountered. Consult with the Nova Hot Line at
1-800-545-NOVA if you have any questions.

10-1

10 Routine Maintenance Stat Profile pHOx Training Manual

NOTES:

10.2.1 Suggested Daily Start-up Procedure

✔ “Housekeeping” Procedures

Discuss modifying this
to meet lab situation.

Verify reagent and control levels.
Review Maintenance Logs for procedures due.

✔ Analyze Controls (Level 1, 2, and 3).

✔ Document QC.

10.2.2Flowpath Cleaning/Deproteinizing

1. Deproteinizing Solution (PN 12704) - used for routine cleaning)
is packaged in ampules. Use this solution when routine clean­ing is required.

The cleaning cycle:

• Removes protein buildup

• Frequency depends on the number of samples or the condi­tion of those samples

• Should be performed when the hematocrit sensor is
uncalibrated

• Must be followed by a full calibration

• Takes 5 minutes

• Can be run at the end of a shift or when most convenient

• Remove the sodium sensor and install a blank.

10-2

See Flowpath Cleaning Procedure Checklists.

10 Routine Maintenance Stat Profile pHOx Training Manual

Flowpath Cleaning Procedure Checklist

NOTES:

Step 1 Remove the Na+ sensor.

• Select Flowpath/Probe Maintenance; wait until system is
finished removing fluid from the flow path.

• Open the door and remove the Na+ sensor. (Squeeze the
front and rear of the black body {sensor clip} and gently pull
it out of the sensor module.)

• Replace it with a blank sensor.

• Press Cancel.

• At pop-up screen, press Cancel again.

Step 2 Begin sample preheater cleaning procedure.

• Press Menu (soft key on the Home screen) to display
Operational Menu.

• Select Flowpath Cleaning.

• Probe extends for aspiration.

Step 3 Prepare solution.

• Open an ampule of Deproteinizing Solution (PN 12704).

Step 4 Present sample and begin cycle.

• Position the ampule over the extended probe.

• Press Continue (soft key) to aspirate the solution.

CAUTION:

the ampule.

Do not allow the sample probe to touch the bottom of

• When the system signals by an audible alarm, remove the
ampule of deproteinizing solution.

• A pop-up screen appears when the aspiration is completed.

10-3

10 Routine Maintenance Stat Profile pHOx Training Manual

NOTES:

Flowpath Cleaning Procedure Checklist

Step 5 Sequence begins.

• Press Analyze.

• Discard any unused solution. Do not save it for use later.

• At the completion of the cycle, a pop-up screen appears
questioning to recalibrate. Press NO.

Step 6 Replace the Na+ sensor.

• Press Menu.

• Select Flowpath/Probe Maintenance.

• Remove blank sensor.

• Install the Na+ sensor.

• Press Continue.

Step 7 Calibrate.

• At the completion of the Flowpath Priming Cycle, a pop-up
screen appears questioning to Recalibrate.
Press Yes.

NOTE:

Menu screen. Press Home (soft key). To calibrate on this screen,
press Calibrate (soft key).

If no is pressed, the analyzer returns to the Operational

10-4

10 Routine Maintenance Stat Profile pHOx Training Manual

NOTES:

10.2.3Flow Cell Conditioning

• Decreases bubble hang-up in the flow cell and at the sensor
tips by wetting the flow cell.

• Coats the sensor membranes with protein to improve their
performance.

• Perform during periods of infrequent sampling and after
flow cell replacement, PO2 or PCO2 sensor maintenance,
and troubleshooting.
Takes 5.5 minutes.

See Flow Cell Conditioning Cycle Checklist.

10-5

10 Routine Maintenance Stat Profile pHOx Training Manual

NOTES:

Flow Cell Conditioning Checklist

Step 1 Prepare sample.

• Fill a 2 mL sample cup 1/2-full with heparinized whole
blood (or serum) or select a syringe containing at least 1 mL
of heparinized whole blood.

Step 2 Begin flow cell conditioning cycle.

• Press Menu (soft key on the Home screen) to display the
Operational Menu screen.

• Select Sensor Conditioning.

• Press Enter

Step 3 Present sample and begin sequence.

• Pour whole blood (or serum) into a cup.

• Position the cup over the extended probe.

CAUTION:

cup.

Do not allow the sample probe to touch the bottom of the

• Press Continue (soft key).

• After the audible alarm, remove the cup.

• Press Analyze. The probe moves downward.

• The sequence begins. Whole blood fills the entire flow path.

• Conditions for 5 minutes. Then flushes the flow cell.

Step 5 Calibrate.

• At the completion of the cycle, a pop-up screen appears
questioning to recalibrate. Press Yes to recalibrate.

NOTE:

Menu screen. Press Home (soft key). To calibrate on this screen,
press Calibrate (soft key).

If no is pressed, the analyzer returns to the Operational

10-6

11 Maintaining Sensors Stat Profile pHOx Training Manual

NOTES:

11 Maintaining Sensors

11.1 Overview

• Correctly functioning sensors are key to obtaining accurate
results.

• Maintenance is essential for sensors to function correctly.

• Frequency of conditioning or replacement is dependent on
the number of samples per day and will vary from lab to lab.

• Monitoring trends and shifts or both in control values and
sensor slope values using your logbook is the best way to
determine an appropriate maintenance interval for your
laboratory.

• Use the maintenance checklists to do preventive mainte­nance or to correct problems.

Before replacing sensors, membranes, etc.:

• Press Menu (soft key) from the Home screen. Then select
Flowpath/Probe Maintenance. Press Enter.

• Remove sensor and shake down.

• Dry sensor and flow cell chamber.

• Reseat sensor.

• Perform calibration.

Table of Contents This section contains maintenance procedures for the
Manual Stat Profile pHOx Analyzer sensors. These procedures

are done as part of a preventive maintenance program or
when a problem occurs. The procedures can be used
during training or for reviewing on your own.

Maintaining Sodium (Na+).................................... 11-3

pH Sensors............................................................ 11-5

Maintaining PCO2 Sensor ....................................11-8

Maintaining PO2 Sensor..................................... 11-12

Maintaining SO2................................................11-17

WARNING

Use appropriate protective face shields, gloves, etc.,
when attempting to flush, clean, or handle any compo­nents of the analyzer which come in contact with blood
specimens.

11-1

11 Maintaining Sensors Stat Profile pHOx Training Manual

NOTES:

Na+ Maintenance Checklist

When Change the Sodium (Na+ ) sensor when it has problems

with slope, instability, overload, or drift.

What You Need Sodium sensor (PN 21523)

Stat Profile pHOx Controls

Stat Profile pHOx Maintenance Log (PN 22362)
Cotton swabs

Step 1 Record slope for comparison purposes.

• Press Menu (soft key on the Home screen) to display the
Operational Menu screen.

• Press Service (soft key) and enter your password to display
the Service Menu screen.

• Select Sensor Subsystem, press Enter, and press Next Page
(soft key) until the Na Calibration & Analysis Data is
displayed.

• Press Print (soft key) to print the slope information.
Save for comparison in Step 7.

• Press Exit (soft key) twice to return to the Operational Menu
screen.

11-2

Step 2 Begin Na+ maintenance.

• Select Flowpath/Probe Maintenance.

• Wait until system is finished removing fluid from the flow
path.

• Open the door.

• Remove the Na+ sensor by squeezing the front and rear of the
black body (sensor clip) and gently pulling it out of the
sensor module.

CAUTION: Do Not condition the Na

+

sensor; you will destroy the sensor.

11 Maintaining Sensors Stat Profile pHOx Training Manual

Na+ Maintenance Checklist

NOTES:

Step 3 Clean and dry the sensor module cuvette with a cotton

swab.

Step 4 Replace with a new sensor.

• Insert a new Sodium Sensor (PN 21523).

STOP

TRAINING CLASS ONLY — Continue with the next sensor.

ø

Step 5 Prime the flow path.

• Close the door.

• Press Continue (soft key) to prime the flow path.

Step 6 Calibrate.

• At the completion of the cycle, a pop-up screen appears
questioning to recalibrate. Press Yes to recalibrate.

• Calibration begins.

NOTE:

Menu screen. Press Home (soft key). To calibrate on this screen,
press Calibrate (soft key).

If no is pressed, the analyzer returns to the Operational

11-3

11 Maintaining Sensors Stat Profile pHOx Training ManualNa+ Maintenance Checklist

NOTES:

Step 7 Review calibration status and slope performance

number.

• Press Menu (soft key on the Home screen) to display the
Operational Menu screen.

• Press Service (soft key) and enter your password to display
the Service Menu screen.

• Select Sensor Subsystem, press Enter, and press Next Page
(soft key) until the Na+ Calibration & Analysis Data is
displayed.
Compare current versus previous slope performance num­bers saved from Step 1.

If higher and within range, continue with Step 8.

or

If not, replace sensor.

Step 8 Verify sensor performance by running controls.

• Run QC samples, 3 levels.

CAUTION:

Controls should be stored at approximately 25°C.

• Verify controls are in range by comparing with data insert
sheet or within lab criteria.

• Record procedure and document quality control results.

11-4

11 Maintaining Sensors Stat Profile pHOx Training Manual

When Condition the pH sensor when the sensor fails to cali-

brate because of low slope or when pH control results are
high.

What You Need pH Sensor Conditioning Solution (PN 23397)

Sensor Conditioning Holder (PN 09458)
Stat Profile pHOx Controls Multipack (PN 22763)

Stat Profile pHOx Maintenance Log (PN 22362)
Lint-free tissues
Cotton swabs
Deionized or distilled water

pH Maintenance Checklist

NOTES:

Step 1 Record slope for comparison purposes.

• Press Menu (soft key on the Home screen) to display the
Operational Menu screen.

• Press Service (soft key) and enter your password to display
the Service Menu screen.

• Select Sensor Subsystem, press Enter, and press Next Page
(soft key) until the pH Calibration & Analysis Data is
displayed.

• Press Print (soft key) to print the slope information.
Save for comparison in Step 7.

• Press Exit (soft key) twice to return to the Operational Menu
screen.

Step 2 Begin pH maintenance.

• Select Flowpath/Probe Maintenance.

• Wait until system is finished removing fluid from the flow
path.

• Open the door.

• Remove the pH sensor by squeezing the front and rear of the
black body (sensor clip) and gently pulling it out of the
sensor module.

11-5

11 Maintaining Sensors Stat Profile pHOx Training ManualpH Maintenance Checklist

NOTES:

Step 3 Condition glass tip, replace, and reconnect sensor.

(Troubleshooting Only)

• Fill bottom chamber of sensor conditioning holder (PN

09458) with pH conditioning solution (PN 23397).
Immerse sensor tip in conditioning solution to soak. The pH
sensor is conditioned for 15 minutes.

• Remove sensor.
Rinse tip with deionized water.

• Dry tip with lint-free tissue.
Dry flow cell with cotton swab covered with lint-free tissue.

• Reinsert sensor.

STOP

TRAINING CLASS ONLY — Continue with the next sensor.

ø

Step 4 Prime the flow path.

• Close the door.

• Press Continue (soft key) to prime the flow path.

• When the priming is completed, a pop-up screen appears to
question for recalibration. Press No.

Step 5 Condition the flow cell.

• From the Operational Menu, select Sensor Conditioning.

NOTE:

Conditioning cycle.

All sensors must be in the flow cell during a Flow Cell

• Fill a 2 mL sample cup 1/2-full with whole blood.

• Insert the probe into the blood.

• Press Continue (soft key) to aspirate the blood.

• After the audible alarm, remove the cup.

• Press Analyze on the pop-up screen. The probe moves
downward. The sequence begins. Whole blood fills the
entire flow path. Conditioning is a 5.5 minute cycle. Then
the system flushes the flow cell.

11-6

11 Maintaining Sensors Stat Profile pHOx Training Manual

pH Maintenance Checklist

NOTES:

Step 6 Calibrate.

• At the completion of the cycle, a pop-up screen appears
questioning to recalibrate. Press Yes to recalibrate.

• Calibration begins.

NOTE:

Menu screen. Press Home (soft key). To calibrate on this screen,
press Calibrate (soft key).

If no is pressed, the analyzer returns to the Operational

Step 7 Review calibration status and slope performance

number.

• Press Menu (soft key on the Home screen) to display the
Operational Menu screen.

• Press Service (soft key) and enter your password to display
the Service Menu screen.

• Select Sensor Subsystem, press Enter, and press Next Page
(soft key) until the pH Calibration & Analysis Data is
displayed.
Compare current versus previous slope performance num­bers saved from Step 1.

If higher and within range, continue with Step 8.

or

If not, replace sensor.

Step 8 Verify sensor performance by running controls.

• Run QC samples, 3 levels.

CAUTION:

Controls should be stored at approximately 25°C.

• Verify controls are in range by comparing with data insert
sheet or within lab criteria.

• Record procedure and document quality control results.

11-7

11 Maintaining Sensors Stat Profile pHOx Training Manual

NOTES:

P

CO2 Maintenance Checklist

When Change the membrane for low slope, controls out of

range, and PCO2 instability, drift, or overload error
codes.

What You Need PCO

Membraned Cap Kit (PN 25048)

2

Stat Profile pHOx Controls Multipack (PN 22763)

Stat Profile pHOx Maintenance Log (PN 22362)
Lint-free tissues
Cotton swabs
Deionized or distilled water
Heparinized whole blood

Step 1 Record slope for comparison purposes.

• Press Menu (soft key on the Home screen) to display the
Operational Menu screen.

• Press Service (soft key) and enter your password to display
the Service Menu screen.

• Select Sensor Subsystem, press Enter, and press Next Page
(soft key) until the PCO2 Calibration & Analysis Data is
displayed.

• Press Print (soft key) to print the slope information.
Save for comparison in Step 12.

• Press Exit (soft key) twice to return to the Operational Menu
screen.

11-8

Step 2 Begin PCO2 Sensor Membraning and Replacement

• Select Flowpath/Probe Maintenance.

• Wait until system is finished removing fluid from the flow
path.

• Open the door.

• Remove the PCO2 Sensor by squeezing the front and rear of
the black body (sensor clip) and gently pulling it out of the
sensor module.

11 Maintaining Sensors Stat Profile pHOx Training Manual

P

CO2 Maintenance Checklist

NOTES:

Step 3 Separate cap and membrane from sensor.

• Unscrew the used membrane cap from the sensor body and
discard it. Dispose of the plastic cap as a biohazard.

CAUTION:

If installing a new sensor, carefully remove the shipping
cap before installing a new membrane cap. Do not touch the
electrical contacts of the sensor.

Step 4 Replace membrane cap on sensor.

NOTE:

filling solution. Do not add or remove any Internal Filling Solu­tion. The prefilled level of solution is all that is needed to operate
the analyzer successfully. Adding or subtracting from the prefilled
level will effect the biosensor's performance.

The prefilled PCO2 cap does not require any additional

• Open foil pouch by tearing at score mark on the bottom of
the package.

• Take a new PCO2 Membrane Cap (PN 25048) that is
prefilled with internal filling solution. Hold the shipping
plug end of the membrane cap and shake it gently, as if
shaking down a thermometer, to ensure that the air bubble
is at the threaded end of the membrane cap.

• Unscrew the black shipping plug from the cap. Screw the
cap onto the sensor. Discard the black shipping plug. Do not
tilt the membrane cap when installing onto the sensor; the
internal filling solution may drip out.

DWG #10-1066A

Figure 11.1 Shaking Down

Membrane Cap

Shipping Plug

See air gap

after shaking

Internal filling solution

DWG #10-1067A

CAUTION:

Do not touch the surface of the membrane.

Step 5 Check for air bubbles at the tip of sensor.

• If new sensor, remove from the foil pack.

• Hold the sensor with the cap downward. With a wrist­snapping motion, shake the sensor down to move air bubbles
to the back of the sensor.

• With the sensor tip still downward, observe the tip for
bubbles. If bubbles are present, tap the sensor with a finger
to loosen the bubbles and again shake the sensor down.
Repeat if necessary.

CAUTION:

Do not point sensor tip upward.

Figure 11.2 Membrane Cap

11-9

11 Maintaining Sensors Stat Profile pHOx Training Manual

NOTES:

123456

P

CO2 Maintenance Checklist

Step 6 Dry the sensor and membrane.

Sensor

Vent Hole

Vent Cover

Figure 11.3 PCO2 sensor

with vent hole covered

• Wipe the sensor body and cap dry.

DWG #10-1068A

• Remove a single vent cover from the blue backing and place
over the vent hole.

• Press firmly to ensure a good seal.

Step 7 Clean the sensor module cuvette with a cotton swab.

Step 8 Replace and reconnect sensor.

• Insert the sensor into the sensor module by sliding the sensor
body into the sensor module until the sensor clips into place.

TRAINING CLASS ONLY —Continue with the next sensor.

STOP

ø

Step 9 Prime the flow path.

• Close the door.

• Press Continue (soft key) to prime the flow path.

• When the priming is completed, a pop-up screen appears to
question for recalibration. Press No. The analyzer returns to
the Operational Menu.

Step 10 Condition the sensor module.

NOTE:

All sensors must be in the sensor module during a Sensor

Conditioning cycle.

• Fill a 2 mL sample cup 1/2-full of whole blood.

• Select Sensor Conditioning from the Operation Menu and
press Enter.

• Immerse the probe in the whole blood.

• Press Continue (soft key) to aspirate the blood.

• After the audible alarm, remove the cup.

11-10

11 Maintaining Sensors Stat Profile pHOx Training Manual

• Press Analyze on the pop-up screen. The probe moves
downward. The sequence begins. Whole blood fills the
entire flow path. Conditioning is a 5.5 minute cycle. Then
the system flushes the flow cell.

P

CO2 Maintenance Checklist

NOTES:

Step 11 Calibrate.

• At the completion of the cycle, a pop-up screen appears
questioning to recalibrate. Press Yes to recalibrate.

• Calibration begins.

NOTE:

Menu screen. Press Home (soft key). To calibrate on this screen,
press Calibrate (soft key).

If no is pressed, the analyzer returns to the Operational

Step 12 Review calibration status and slope performance number.

• Press Menu (soft key on the Home screen) to display the
Operational Menu screen.

• Press Service (soft key) and enter your password to display
the Service Menu screen.

• Select Sensor Subsystem, press Enter, and press Next Page
(soft key) until the PCO2 Calibration & Analysis Data is
displayed.
Compare current versus previous slope performance num­bers saved from Step 1.

If higher and within range, continue with Step 13.

or

If not, replace sensor.

Step 13 Verify sensor performance by running controls.

• Run QC samples, 3 levels.

CAUTION:

Controls should be stored at approximately 25°C.

• Verify controls are in range by comparing with data insert
sheet or within lab criteria.

• Record procedure and document quality control results.

11-11

11 Maintaining Sensors Stat Profile pHOx Training Manual

NOTES:

P

O2 Maintenance Checklist

When You will need to polish and remembrane the oxygen

(PO2) sensor if you are experiencing a problem such as
slope out of range, controls out of range, or drift error
codes on analysis.

What You Need PO2 Premembraned Cap Kit (PN 21795)

Stat Profile pHOx Controls Multipack (PN 22763)

Stat Profile pHOx Maintenance Log (PN 22362)
Polishing paper
Lint-free tissues
Cotton swabs
Deionized or distilled water
Heparinized whole blood

Step 1 Record slope for comparison purposes.

• Press Menu (soft key on the Home screen) to display the
Operational Menu screen.

• Press Service (soft key) and enter your password to display
the Service Menu screen.

• Select Sensor Subsystem, press Enter, and press Next Page
(soft key) until the PO2 Calibration & Analysis Data is
displayed.

• Press Print (soft key) to print the slope information.
Save for comparison in Step 13.

• Press Exit (soft key) twice to return to the Operational Menu
screen.

Step 2 Begin PO2 Sensor Polishing, Membraning, and Replace-

ment

• Select Flowpath/Probe Maintenance.

• Wait until system is finished removing fluid from the flow
path.

• Open the door.

• Remove the PO2 Sensor by squeezing the front and rear of
the black body (sensor clip) and gently pulling it out of the
sensor module.

11-12

11 Maintaining Sensors Stat Profile pHOx Training Manual

P

O2 Maintenance Checklist

NOTES:

Step 3 Separate cap and membrane from sensor.

• Unscrew the used membrane cap from the sensor body and
discard it.
Dispose of the plastic cap as a biohazard.

Step 4 Polish the sensor (Troubleshooting only).

• If troubleshooting, polish the sensor: if not, skip to Step 5.

• Take a polishing paper and place a couple of drops of
deionized water onto it.

• Hold the PO2 polishing paper so that the tip of your index
finger provides light pressure against the back of the paper.

• Gently polish the sensor tip on the paper, move the tip in a
circular motion for about 10 seconds.

CAUTION:

bench top.

• Discard the used polishing paper.

• Wipe the sensor tip with a lint-free tissue soaked in deion-

Never polish the sensor on a hard surface such as a

ized water.

Step 5 Replace membrane cap on sensor.

• Open foil pouch by tearing at score mark on the bottom of
the package.

• Take a new PO2 Premembraned Cap (PN 21795) that is
prefilled with internal filling solution, and shake it gently to
ensure that the solution is away from the threaded end and
at the membrane end. Unscrew and discard the shipping
plug from the cap.

• Insert the sensor body straight down (vertical position only
to ensure no loss of internal filling solution) into the filled
cap and screw the cap onto the sensor body.

CAUTION:

Do not touch the surface of the membrane.

The prefilled PO2 cap

does not require any

additional filling

solution. Do not add

or remove any Internal

Filling Solution. The

prefilled level of

solution is all that is

needed to operate

the analyzer

successfully. Adding

or subtracting from

the prefilled level will

effect the biosensor's

performance.

11-13

11 Maintaining Sensors Stat Profile pHOx Training Manual

NOTES:

P

O2 Maintenance Checklist

Step 6 Check for air bubbles at the tip of sensor.

• Hold the sensor with the cap downward. With a wrist­snapping motion, shake the sensor down to move air bubbles
to the back of the sensor.

• With the sensor tip still downward, observe the tip for
bubbles. If bubbles are present, tap the sensor with a finger
to loosen the bubbles and again shake the sensor down.
Repeat if necessary.

CAUTION:

Do not point sensor tip upward.

Step 7 Dry the sensor and membrane.

• Dry the sensor with a lint-free tissue.

• Do not touch the membrane.

Step 8 Clean the sensor module cuvette with a cotton swab.

Step 9 Check for air bubbles, replace and reconnect sensor.

• Remove air bubbles by repeating Step 6.

• Insert the sensor into the sensor module by sliding the sensor
body into the sensor module until the sensor clips into place.

11-14

STOP

ø

TRAINING CLASS ONLY —Continue with the next sensor.