HctRequires 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).
HgbRequires 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).
P50Measured 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 QtRequires 2 separate blood samples for determination: mixed venous and arterial.
RIUtilizes 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.
Replace PCO2 CapReplace SensorsReplace Printer Paper
QR-2
Quick ReferenceStat 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 GasesSO2
PO2/PCO2
Results HighVerify controls are at room temperature
or Low
Check for low slope
Change membrane
Change sensorResults HighVerify controls are at room temperature
Debubble sensoror LowCheck 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 restrictionsChange reference electrode
Results HighRecalibrate, clean cuvette and sensor,
or Lowinspect or replace washer
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
PrefaceStat 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
PrefaceStat 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 IdentificationStat Profile pHOx Training Manual
NOTES:
1System Identification
1.1System 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 IdentificationStat 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 Line7. Sampler
2. Reference Line8. Air Detector
3. Pinch Valve (Reference)9. Sensor Module with Sensors
4. Pump and Pump Tubing10. Reference Electrode
5. Reagent Pack Opening11. Pinch Valve (Waste)
6. Control Pack Opening
1 System IdentificationStat Profile pHOx Training Manual
NOTES:
1.2Flow 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.
1.3Flow 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 IdentificationStat 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 IdentificationStat 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
The sensors clip into the sensor module, and an electrical contact is
automatically made.
1-5
1 System IdentificationStat 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 IdentificationStat 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 IdentificationStat Profile pHOx Training Manual
NOTES:
1-8
2 Running an AnalysisStat Profile pHOx Training Manual
NOTES:
2 Running an Analysis
2.1Is 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.
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 AnalysisStat 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 AnalysisStat 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 AnalysisStat 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.
2.3Sample Information
2.4Results 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.
2.5Running an Analysis Exercise
See Running an Analysis Checklist to perform the lab.
2.6Standby Mode
See Standby Mode Checklist to perform the lab.
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