pH Advanced Technology for

Stat Profile pHOx Series

® ®

PCO2 Blood Gas and Critical Care Analyses

PO2
SO2%
Hct
Hb
Na +
Stat Profile pHOx Basic
K+ Stat
Blood Gas Profile
pH PCO PO 2 2
Profile pHOx Oximetry Blood Gas/Oximetry Profile
pH PCO PO SO % Hct Hb
Ca++ Stat
2 2 2
Profile pHOx Respiratory Blood Gas/Respiratory Profile
pH PCO PO SO % Hct Hb Lac
2 2 2
Stat Profile pHOx Plus
Cl pHStat PCO
-
Critical Care Profile
+ + ++ -
2PO SO % Hct Hb Na K Ca Cl Glu
2 2 or
Profile pHOx Plus C Critical Care Profile
+ + ++ -
pH PCO PO SO % Hct Hb Na K Ca Cl Glu
Glu pHStat PCO
2 2 2
Profile pHOx Plus L Critical Care Profile
+ + ++ -
2PO SO % Hct Hb Na K Ca Cl Glu Lac
2 2 or

Lac
Six Models with Blood Gas Fast Stat Results
and Critical Care Menus Stat Profile pHOx analyzers process samples rapidly. All
test results are available and are displayed on-screen in 45
Using a unique combination of advanced optical and elec- seconds (pHOx Oximetry and pHOx Basic), 50 seconds
trode technology, Stat Profile pHOx® analyzers offer blood gas (pHOx Plus), or 52 seconds
or point-of-care (POC) test menus. (pHOx Plus C, pHOx Plus
L, and pHOx Respiratory).
The Stat Profile pHOx Basic test menu consists of pH, PCO2, Throughput rates are 50
and PO2. The other five pHOx menus include pH, PCO2, samples per hour for pHOx
PO2 and add choices of measured hemoglobin, hematocrit, Basic and pHOx Oximetry,
SO2%, glucose, lactate, sodium, potassium, calcium and 44 samples per hour for the
chloride assays in the combinations shown in the table below. pHOx Plus and pHOx Plus
A unique technology feature of Nova Stat Profile analyzers C, and 40 samples per hour
is that they can measure hemoglobin, hematocrit and SO2% for the pHOx Plus L and
on each sample without the added cost and added sample pHOx Respiratory.
volume of a CO-Oximeter. For many users, these basic
oxygenation tests greatly reduce the number of separate CO-
Oximetry analyses that need to be done. However, when a full
CO-Oximeter profile, including the hemoglobin fractions, is

All Liquid Calibration Cartridge

needed, a Stat Profile pHOx CO-Oximeter is available.
pHOx Models/Menus
Stat Profile pHOx Basic:
pH PCO2 PO2
Eliminates Gas Tanks
A new, liquid-only calibration cartridge eliminates bulky
Stat Profile pHOx Oximetry: compressed gas tanks, gas regulators, gas tubing lines,
pH PCO2 PO2 SO2% Hct Hb and humidifiers. A single cartridge contains all calibra-
Stat Profile pHOx Respiratory: tors. This integrated gas
pH PCO2 PO2 SO2% Hct Hb Lac and reagent packaging
Stat Profile pHOx Plus: system replaces up to five
pH PCO2 PO2 SO2% Hct Hb Na+ K+ Glu Ca++ or Cl- individual reagent bottles
and two gas tanks with a
Stat Profile pHOx Plus C: simple, snap-in reagent
pH PCO2 PO2 SO2% Hct Hb Na+ K+ Glu Ca++ and Cl-
cartridge. The single car-
Stat Profile pHOx Plus L: tridge also eliminates the
pH PCO2 PO2 SO2% Hct Hb Na+ K+ Glu Lac Ca++ or Cl-
need to maintain logs and
run both calibration and
Advanced Analytics QC procedures each time
one of the five individual
Microsensors reagent bottles or two gas
New, smaller electrode tanks is replaced. When
designs create several the calibration cartridge
improvements. A 45 is used, all calibrator values, fluid volumes, and expiration
microliter blood sample dates are automatically downloaded to the computerized
Reagent Management System (RMS). Fluid consumption
is offered for pediatric
is then automatically monitored and calibration reagent levels
patients. New disposable are displayed on-screen. In addition, the calibration cartridge
sensor elements eliminate includes a sealed waste container that stores the sample and
electrode maintenance. reagent waste. The waste container is completely enclosed
When a disposable element for safety and ease of disposal.
needs to be replaced, it can
be done in seconds.
Optics
Oxygen saturation and
hemoglobin are measured
based upon advanced
multi-wavelength optical
reflectance technology.
Measured vs. Calculated
SO2%without CO-Oximeter
Measured rather than calculat-
ed oxygen saturation (SO2%)
is officially recognized by
the National Committee for
Clinical Laboratory Standards (NCCLS) as necessary for accurate
assessment of oxygen saturation. The 1997 NCCLS Standard
C-25A recommends that calculated SO2% values of blood gas
analyzers not be used to assess a patientʼs oxygenation status
because of the potential errors that can result.1 All models except
the Stat Profile pHOx Basic provide measured SO2% without
the need for a separate CO-Oximeter.
On-Board Cartridge QC Small Sample Volume
Automates Quality Control Blood conservation is an important initiative in every critical
care department, especially the NICU. The average daily
Novaʼs Auto-Cartridge QC is a totally automated qual- blood loss due to laboratory tests in critically ill patients
ity control system contained within a single on-board is 25 to 125 mL/day per patient.2,3,4 Stat Profile pHOx ana-
control cartridge. This unique system combines multiple lyzer sample volumes are important contributors to blood
levels of controls and dedicated software allowing any level conservation with volumes as low as 45 µL for blood gas
of quality control to be run at any time, either on a pre- and only 125 µL for a full 11 test menu.
programmed schedule or on demand.
Full Panel Micro Panel
Time and Labor Savings (pH, PCO2, PO2)
For most users, analyz- Stat Profile 70 µL 45 µL
ing controls and entering pHOx Basic (3 tests) (3 tests)
quality control data require
more time and labor than
any other aspect of blood Stat Profile 70 µL 45 µL
gas testing. The Auto- pHOx Oximetry (6 tests) (3 tests)
Cartridge QC system dra-
matically reduces costs by Stat Profile 125 µL 60 µL
eliminating the time and pHOx Respiratory (7 tests) (3 tests)
labor required to manually
perform quality control. Stat Profile 115 µL 55 µL
Each Nova Auto-Cartridge pHOx Plus (10 tests) (3 tests)
contains three levels of blood chemistry controls, two
levels of SO2%, hematocrit and hemoglobin controls, and Stat Profile 125 µL 60 µL
software which automates running controls and storing pHOx Plus C (11 tests) (3 tests)
quality control data.
Stat Profile 125 µL 60 µL
When the cartridge is installed, all quality control target
pHOx Plus L (11 tests) (3 tests)
ranges, lot code, and expiration date are automatically
downloaded to the analyzer.
Automatic QC Analysis
The user can program the analyzer to automatically analyze
Compact POC Design
up to three quality control levels, three times per day. Stat Profile pHOx analyzers are the smallest in-
struments offering their respective test menus.
Auto Repeat and Flagging The analyzer footprint is only 12” wide by
If any analyte value is outside the target range, it is automati- 15” deep by 15” tall (31 cm x 38 cm x 38 cm),
cally reanalyzed; if a control value remains outside of range, including on-board reagents and controls, and
the user is notified. a sealed waste container to store used reagents
and samples. These analyzers weigh less than
Automatic Data Storage and Reporting 20 pounds (9 kg) and are easily transported on
All quality control data is automatically stored. Daily and cu- the optional pHOx Cart with an uninterruptible
mulative statistical reports and Levey-Jennings graphs can be power manager.
printed at any time. This automation not only eliminates labor,
it assures that quality control is always performed accurately
and on schedule, and guarantees regulatory compliance.
Automated Activation from Standby
If the analyzer is put into standby mode for several hours or Easy, Safe Capillary or
Syringe Use
days, it can be programmed to automatically restart, calibrate
itself, and perform QC at a pre-selected time and date.
QC Lockout The Stat Profile pHOx sampler is designed for fast, easy
An optional QC lockout feature programs the analyzer to use and operator safety. For samples in syringes, the
suppress test results for any analyte that is not within its sampler probe automati-
control range. cally positions itself at the
optimal angle. For capil-
lary samples, the sampler
automatically presents a
universal capillary sam-
pling port in a horizon-
tal position to prevent
spillage or dripping. As
sampling is performed
directly from the capil-
lary, no adapter or sample
transfer is required. This
assures that sample integ-
rity and operator safety
are optimized. Following sample aspiration from either sy-
ringes or capillaries, the sampler moves to an internal wash
position and is automatically cleaned.
Benefits for the
Physician, Laboratory,
and Management
For the Physician:
Improved Diagnosis
• Comprehensive diagnosis of patient
acid/base oxygenation status plus key
electrolyte, metabolite and hematology
parameters.
• Small sample size for pediatric patients.
• 52 second stat analysis time for the full 11
test panel.
For the Laboratory:
Time and Labor Savings
• On-board QC system eliminates running
controls and entering data.
• Eliminating bulky gas tanks, regulators,
humidifiers, and tubing lines avoids ongoing
replacement and maintenance.
• Single calibration cartridge eliminates labor
required to replace consumable items and
perform separate recalibrations and QC
procedures.
• Sealed on-board waste container with
enclosed biocide can be disposed without
operator contact to blood waste.
• Disposable sensor elements require no daily
maintenance, have long operating lives, and
can be replaced in seconds.
For Management:
Real Cost Savings
• On-board QC ensures quality control, and
eliminates 80% of the daily labor required
to perform quality controls.
• Advanced microsensors, surface mount elec-
tronics, and reagent packaging significantly
reduce analyzer cost and reagent consump-
tion.
• Elimination of sensor maintenance, gas tank
replacement, emptying and cleaning waste
containers, cleaning gas lines, regulators,
and humidifiers substantially reduces operat-
ing labor and inventory costs.
• Enhanced clinician satisfaction due to rapid
turnaround of key diagnostic information.
A Complete POC
Connectivity Solution
Any number of Nova analyzers can be interfaced
with Novaʼs powerful Point-of-Care Data Man-
ager (PDM) software.
This connectivity software provides a flexible,
integrated POC system performing these key
functions:
Process Automation
PDM automates the order entry, accessioning, and
reporting process. This process automation soft-
ware reduces turnaround time, eliminates manual
order entry and data reporting, prevents data er-
rors, and improves efficiency of operation.
Remote Control
The lab can remotely view instrument status
and initiate an automated analyzer calibration,
maintenance cycle, or on-board QC testing for a
POC analyzer. It also can restrict analyzer use by
password access, and permit the lab to enable or
disable any test channel on the analyzer.
Remote Review
PDM enables the central laboratory to have a
constant overview of POC analyzers located at
the point-of-care. Laboratory staff can review,
verify, edit, store, and print POC test results,
quality control, and instrument calibration with-
out ever leaving the laboratory.
Data Capture
PDM captures data from multiple analyzers and
connects with the LIS and HIS for seamless
integration of data. PDM is the gateway to an
open system allowing connectivity of instru-
ments from other POC vendors. The HL7 data
format used by the PDM allows for universal
connectivity to any LIS system.
Password Protection
All pHOx analyzers accept up to 200 individual
passwords with multiple privilege levels, thereby
restricting access to authorized individuals only.
Further, a test suppression function permits the
lab to enable or disable any test channel on
the analyzer.
Point-of-Care Data Manager (PDM)
HIS
POC Point-of-Care
Analyzer Data
Manager LIS
Laboratory, respiratory Controls any number Laboratory and Hospital
or point-of-care locations of analyzers Information Systems
Stat Profile pHOx Series Analytical Specifications for Imprecision
(Normal Aspiration Mode): Stat Profile pHOx Series
Specifications Within-Run Imprecision
n=20 Whichever is Greater
Day-to-Day Imprecision
n=20 Whichever is Greater Co-Oximeter Specifications
Analyte CV% SD CV% SD
Na+ 1.0 1.0 (mmol/L) 1.5 1.0 (mmol/L)
K+ 1.5 0.15 (mmol/L) 3.0 0.15 (mmol/L)
Ca++ 2.0 0.05 (mmol/L) 4.0 0.05 (mmol/L)
Glucose 5.0 2.0 (mmol/L) 6.5 3.0 (mmol/L)
Lactate 3.0 0.3 (mmol/L) 6.0 3.0 (mmol/L)
Cl- 1.5 2.0 (mmol/L) 2.5 2.0 (mmol/L)
SO2% N/A 1.0 % N/A 1.5 %
PCO2 3.0 1.0 (mmHg) 5.0 2.0 (mmHg)
PO2 (< 400 mmHg) 3.0 1.5 (mmHg) 5.0 3.0 (mmHg)
PO2 (> 400 mmHg) 6.0 – 10.0 –
Hct N/A 1.0 % N/A 1.0 Hct%
pH N/A 0.005 N/A 0.013
Hb 2.5 0.3 g/dL 2.5 0.3 g/dL
Acceptable Samples:
Whole blood (heparinized), arterial, mixed venous, capillary,
Measured Tests Methodology serum plasma (pHOx Plus L only) Test Menu:
Na+ ............................. Direct ISE COHb, carboxyhemoglobin; HHb, deoxyhemoglobin;
K+ ............................... Direct ISE Analysis Rate: Stat Analysis Time Throughput Rate O 2 Hb, oxyhemoglobin; MetHb, methemoglobin;
Ca++ ............................. Direct ISE pHOx Basic 45 seconds 50/hour tHb, total hemoglobin; SO2%, oxygen saturation; O2Ct,
Glucose......................... Enzyme/Amperometric pHOx Oximetry 45 seconds 50/hour oxygen content; O2Cap, oxygen capacity
Lactate.......................... Enzyme/Amperometric pHOx Respiratory 52 seconds 40/hour
pHOx Plus 50 seconds 44/hour Monitored Interferences:
Cl- ................................ Direct ISE pHOx Plus C 52 seconds 44/hour SulfHb, sulfhemoglobin
pH ................................ Direct ISE pHOx Plus L 52 seconds 40/hour (Measured; user alerted if abnormal, > 1.5%)
PCO2 .......................... Severinghaus
PO2 ............................... Amperometric Sample Volume pHOx Basic: Sample Volume: 115 µL
SO2% ............................ Optical, reflectance 45 microliters whole blood micro sample for pH/PCO2/PO2 Cycle Time: 80 seconds
Hematocrit .................. Conductivity/Na+ correction 70 microliters whole blood sample size for full panel
Samples/Hour: 45
Hemoglobin ................. Multi-wavelength reflectance/ Sample Volume pHOx Oximetry:
conductivity correction 45 microliters whole blood micro sample for blood gases/pH Sample Type: Heparinized whole blood
Calculated: 70 microliters whole blood sample size for full panel Operating Ranges:
Tests- Resolution Tests Resolution Sample Volume pHOx Respiratory: COHb ..........0 to 100 % HHb............0 to 100 %
HCO3 0.1 mmol/L a/A 0.1 60 microliters whole blood micro sample for blood gases/pH O2Hb............0 to 100 % MetHb ........0 to 100 %
TCO2 0.1 mmol/L PO2/FIO2 0.1 125 microliters whole blood sample size for full panel SO2% ...........0 to 100 % O2Ct............0 to 40.3 vol%
Be-ecf 0.1 mmol/L Anion Gap 0.1 mmol/L Sample Volume pHOx Plus: O2Cap..........0 to 40.3 vol% tHb..............5 to 30 g/dL
B-eb 0.1 mmol/L SBC 0.1 mmol/L 55 microliters whole blood micro sample for blood gases/pH sHb..............Alert > 1.5%
O2Ct 0.1 mL/dL (1 mL/L) 115 microliters whole blood sample size for full panel Physical Specifications:
A 0.1 mmHg (0.01 kPa) Sample Volume pHOx Plus C and pHOx Plus L: Height 15.0 in (38.1 cm) Width 12.0 in (30.5 cm)
A-aDO2 0.1 mmHg (0.01 kPa) 60 microliters whole blood micro sample for blood gases/pH Depth 15.0 in (38.1 cm)
Special Calculated Tests (CO-Oximeter Required): 125 microliters whole blood sample size for 11 test panel Weight: 18 lb (8.19 kg) without reagent pack
Tests Resolution Electrical Requirements: 90-264 VAC, 50/60 Hz, 200W Electrical Power Requirements: 90-264 VAC, 50/60 Hz
Qsp/Qt 0.1 Data Ports:
A-v DO2 0.1 mmHg (0.01 kPa) Interfaces: RS232 serial, ASTM Standard data protocol
2 bidirectional serial I/O data ports, 1 printer port
CaO2 0.1 mmHg (0.01 kPa) Temperature Thermostatting: 37°C ± 0.1°C 1 port for optional external bar code reader
CcO2 0.1 mmHg (0.01 kPa) Printer: 52 Column thermal — Built in
P50 0.1 mmHg (0.01 kPa) Printer Options:
FDA Labeling: For in-vitro diagnostic use External, 8-1/2” x 11” dot matrix
Measurement Range: Calibration: User-selectable, fully automatic two-point External thermal roll printer
Na+ 80 - 200 mmol/L calibration every 2, 4, or 6 hours; user-selectable, single-point Display Languages (user selectable):
K+ 1 - 20 mmol/L calibration every 30/45 minutes or with each sample (pHOx English, French, German, Italian, Japanese, and Spanish
Ca++ 0.1 - 2.7 mmol/L Plus and pHOx Plus L are fixed at 30 minutes or with each
Glu 15 - 500 mg/dL Optical System: Spectrophotometer
sample); manual calibration initiated at any time.
Lac 0.3 - 20 mmol/L Wavelengths Measured: 557, 577, 597, 605, 624, 635, 650 nm
Cl- 50 - 200 mmol/L NOVA BIOMEDICAL HEADQUARTERS
200 Prospect Street, Waltham, MA 02454-9141 U.S.A.
Light Source: Halogen
pH 6.50 - 8.00 (H+: 316.23 - 10.00 mmol/L) TEL: (781) 894-0800 (800) 458-5813 FAX: (781) 894-5915 Expected Light Source Use Life: 50,000 Hours (5+ Years)
PCO2 3.0 - 200 mmHg (0.4 - 26.7 kPa) NOVA BIOMEDICAL AUSTRIA
Laxenburgerstrasse 33/6, 1100 Vienna, Austria Cuvette Temperature Control: 37°C ± 0.5°C
PO2 0 - 800 mmHg (0.0 - 106.7 kPa) TEL: (43) 1-603 09 700 FAX: (43) 1-603 09 702
SO2% 30 - 100 % (0.3 - 1.00) NOVA BIOMEDICAL CANADA, LTD
6810 Kitimat Road, Unit 5, Mississauga, Ontario L5N 5M2 Canada
Certifications: ISO 9001 Quality System Registration, CSA,
Hb 4.0 - 24.0 g/dL (2.5 - 14.9 mmol/L) TEL: (905) 567-7700 (800) 263-5999 FAX: (905) 567-5496 TÜV, CE Self Declared Complies to EN 61010, EN 50081,82
NOVA BIOMEDICAL FRANCE
Hct 12% - 70% (12 - 60% for micro in Plus family Z.I. de Courtaboeuf, 15 Avenue du Quebec, B.P. 632, 91965
Les Ulis Cedex, France TEL: (33) 1-69188140 FAX: (33) 1-69070160
and pHOx Respiratory) NOVA BIOMEDICAL GmbH
BarP 400.0 - 800.0 mmHg (53.3 -106.7 kPa) Adam-Opel-Str. 19 A, D 63322 Rödermark, F.R. Germany References
TEL: (49) 6074-8448-0 FAX: (49) 6074-844833 1
National Committee for Clinical Laboratory Standards.
Major Features: e-mail: info@novabiomedical.de
NOVA BIOMEDICAL INDIA Fractional Oxyhemoglobin, Oxygen Content and Saturation,
1/4 VGA color display (color available 6/1/05)- multilingual, 117C, Sector-2, Pocket-2, Dwarka, New Delhi 110075 India and Related Quantities in Blood: Terminology, Measurement
visible flow path, automatic QC, QC statistics reports, Levey- TEL: +91 11 2508 9217 +91 11 2508 2664 FAX: +91 11 2508 9018 and Reporting. Villanova, PA: NCCLS; 1997.
e-mail: novabio@nde.vsnl.net.in 2
Excessive Blood Drawing for Laboratory Tests. Hicks, J.M.,
Jennings plots, gasless calibration (no tanks or regulators), NOVA BIOMEDICAL K.K.
B-3F Omori Bellport, 26-MinamiOi 6-chome, The New England Journal of Medicine, May 27, 1999;1690.
automatic sampler, integral capillary adapter, PCMCIA type Shinagawa-ku, Tokyo 140-0013, Japan
3
Evaluation of a new blood-conserving arterial line system for
program changer, optional CCD bar code scanner, single TEL: (03) 5471-5461 FAX: (03) 5471-5474 patients in intensive care units. Silver, M.J., Juhran, H., Stein,
e-mail: nakamura@novabiomedical.co.jp S., et al. Critical Care Medicine, 1993; 21, 507-511.
snap-in reagent system, arterial venous physiological shunt NOVA BIOMEDICAL U.K. 4
Blood conservation in critical care: the evidence accumulates.
C3-5, Evans Business Centre, Deeside Industrial Park,
mode, QC data storage, combined CO-Oximetry and blood gas Deeside, Flintshire CH5 2JZ United Kingdom Chernow, B. Critical Care Medicine, 1993; 21, 481-482.
results, ventilator settings, draw puncture site TEL: (44) 1244 287087 FAX: (44) 1244 287080
e-mail: office@novabiomedical.co.uk
Certifications: ISO 9001 Quality System Registration, CSA, IN THE U.S., call toll-free 800-458-5813
IN CANADA, call toll-free 800-263-5999
TÜV, CE Self Declared Complies to EN 61010, EN 50081,82 Internet address: www.novabiomedical.com
e-mail: info@novabiomedical.com
Physical Specifications: Height: 15.0 in (38.1 cm) Specifications are subject to change without notice. No. 85 3/06
Width: 12.0 in (30.5 cm) Depth: 15.0 in (38.1 cm)
Weight: 18 lb (8.19 kg) without reagent pack