Download pH PCO2 PO2 SO2% Hct Hb Na+ K+ Ca++ Cl

pH Advanced Technology for
PCO2 Blood Gas and Critical Care Analyses
PO2
SO2%
Hct
Hb
+
Na
Stat Profile pHOx Basic
pH PCO PO
K+ Stat
Profile pHOx Oximetry
pH PCO PO SO % Hct Hb
Profile pHOx Respiratory
Ca++ Stat
pH PCO PO SO % Hct Hb Lac
Stat Profile pHOx Plus
PO SO % Hct Hb Na K Ca Cl Glu
Cl pHStat PCO
Profile pHOx Plus C
pH PCO PO SO % Hct Hb Na K Ca Cl Glu
Profile pHOx Plus L
Glu pHStat PCO
PO SO % Hct Hb Na K Ca Cl Glu Lac
Lac
Stat Profile pHOx Series
®
®
Blood Gas Profile
2
2
Blood Gas/Oximetry Profile
2
2
2
Blood Gas/Respiratory Profile
2
2
2
Critical Care Profile
+
2
2
Critical Care Profile
+
2
2
+
2
++
-
+
++
-
+
++
-
or
2
Critical Care Profile
2
+
2
2
or
Six Models with Blood Gas
and Critical Care Menus
Using a unique combination of advanced optical and electrode technology, Stat Profile pHOx® analyzers offer blood gas
or point-of-care (POC) test menus.
The Stat Profile pHOx Basic test menu consists of pH, PCO2,
and PO2. The other five pHOx menus include pH, PCO2,
PO2 and add choices of measured hemoglobin, hematocrit,
SO2%, glucose, lactate, sodium, potassium, calcium and
chloride assays in the combinations shown in the table below.
A unique technology feature of Nova Stat Profile analyzers
is that they can measure hemoglobin, hematocrit and SO2%
on each sample without the added cost and added sample
volume of a CO-Oximeter. For many users, these basic
oxygenation tests greatly reduce the number of separate COOximetry analyses that need to be done. However, when a full
CO-Oximeter profile, including the hemoglobin fractions, is
needed, a Stat Profile pHOx CO-Oximeter is available.
pHOx Models/Menus
Stat Profile pHOx Basic:
pH PCO2 PO2
Stat Profile pHOx Oximetry:
pH PCO2 PO2 SO2% Hct Hb
Stat Profile pHOx Respiratory:
pH PCO2 PO2 SO2% Hct Hb Lac
Stat Profile pHOx Plus:
pH PCO2 PO2 SO2% Hct Hb Na+ K+ Glu Ca++ or Cl-
Stat Profile pHOx Plus C:
pH PCO2 PO2 SO2% Hct Hb Na+ K+ Glu Ca++ and Cl-
Stat Profile pHOx Plus L:
pH PCO2 PO2 SO2% Hct Hb Na+ K+ Glu Lac Ca++ or Cl-
Advanced Analytics
Microsensors
New, smaller electrode
designs create several
improvements. A 45
microliter blood sample
is offered for pediatric
patients. New disposable
sensor elements eliminate
electrode maintenance.
When a disposable element
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 calculated 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.
Fast
Stat Results
Stat Profile pHOx analyzers process samples rapidly. All
test results are available and are displayed on-screen in 45
seconds (pHOx Oximetry and pHOx Basic), 50 seconds
(pHOx Plus), or 52 seconds
(pHOx Plus C, pHOx Plus
L, and pHOx Respiratory).
Throughput rates are 50
samples per hour for pHOx
Basic and pHOx Oximetry,
44 samples per hour for the
pHOx Plus and pHOx Plus
C, and 40 samples per hour
for the pHOx Plus L and
pHOx Respiratory.
All Liquid Calibration Cartridge
Eliminates Gas Tanks
A new, liquid-only calibration cartridge eliminates bulky
compressed gas tanks, gas regulators, gas tubing lines,
and humidifiers. A single cartridge contains all calibrators. This integrated gas
and reagent packaging
system replaces up to five
individual reagent bottles
and two gas tanks with a
simple, snap-in reagent
cartridge. The single cartridge also eliminates the
need to maintain logs and
run both calibration and
QC procedures each time
one of the five individual
reagent bottles or two gas
tanks is replaced. When
the calibration cartridge
is used, all calibrator values, fluid volumes, and expiration
dates are automatically downloaded to the computerized
Reagent Management System (RMS). Fluid consumption
is then automatically monitored and calibration reagent levels
are displayed on-screen. In addition, the calibration cartridge
includes a sealed waste container that stores the sample and
reagent waste. The waste container is completely enclosed
for safety and ease of disposal.
On-Board Cartridge QC
Automates Quality Control
Novaʼs Auto-Cartridge QC is a totally automated quality control system contained within a single on-board
control cartridge. This unique system combines multiple
levels of controls and dedicated software allowing any level
of quality control to be run at any time, either on a preprogrammed schedule or on demand.
Small Sample Volume
Blood conservation is an important initiative in every critical
care department, especially the NICU. The average daily
blood loss due to laboratory tests in critically ill patients
is 25 to 125 mL/day per patient.2,3,4 Stat Profile pHOx analyzer sample volumes are important contributors to blood
conservation with volumes as low as 45 µL for blood gas
and only 125 µL for a full 11 test menu.
Full Panel
Stat Profile
pHOx Basic
70 µL
(3 tests)
Micro Panel
(pH, PCO2, PO2)
45 µL
(3 tests)
Stat Profile
pHOx Oximetry
70 µL
(6 tests)
45 µL
(3 tests)
Stat Profile
125 µL
pHOx Respiratory (7 tests)
60 µL
(3 tests)
Stat Profile
pHOx Plus
115 µL
(10 tests)
55 µL
(3 tests)
Stat Profile
pHOx Plus C
125 µL
(11 tests)
60 µL
(3 tests)
Stat Profile
pHOx Plus L
125 µL
(11 tests)
60 µL
(3 tests)
Time and Labor Savings
For most users, analyzing controls and entering
quality control data require
more time and labor than
any other aspect of blood
gas testing. The AutoCartridge QC system dramatically reduces costs by
eliminating the time and
labor required to manually
perform quality control.
Each Nova Auto-Cartridge
contains three levels of blood chemistry controls, two
levels of SO2%, hematocrit and hemoglobin controls, and
software which automates running controls and storing
quality control data.
When the cartridge is installed, all quality control target
ranges, lot code, and expiration date are automatically
downloaded to the analyzer.
Automatic QC Analysis
The user can program the analyzer to automatically analyze
up to three quality control levels, three times per day.
Auto Repeat and Flagging
If any analyte value is outside the target range, it is automatically reanalyzed; if a control value remains outside of range,
the user is notified.
Automatic Data Storage and Reporting
All quality control data is automatically stored. Daily and cumulative statistical reports and Levey-Jennings graphs can be
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
days, it can be programmed to automatically restart, calibrate
itself, and perform QC at a pre-selected time and date.
QC Lockout
An optional QC lockout feature programs the analyzer to
suppress test results for any analyte that is not within its
control range.
Compact POC Design
Stat Profile pHOx analyzers are the smallest instruments offering their respective test menus.
The analyzer footprint is only 12” wide by
15” deep by 15” tall (31 cm x 38 cm x 38 cm),
including on-board reagents and controls, and
a sealed waste container to store used reagents
and samples. These analyzers weigh less than
20 pounds (9 kg) and are easily transported on
the optional pHOx Cart with an uninterruptible
power manager.
Easy, Safe Capillary or
Syringe Use
The Stat Profile pHOx sampler is designed for fast, easy
use and operator safety. For samples in syringes, the
sampler probe automatically positions itself at the
optimal angle. For capillary samples, the sampler
automatically presents a
universal capillary sampling port in a horizontal position to prevent
spillage or dripping. As
sampling is performed
directly from the capillary, no adapter or sample
transfer is required. This
assures that sample integrity and operator safety
are optimized. Following sample aspiration from either syringes 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 electronics, and reagent packaging significantly
reduce analyzer cost and reagent consumption.
• Elimination of sensor maintenance, gas tank
replacement, emptying and cleaning waste
containers, cleaning gas lines, regulators,
and humidifiers substantially reduces operating 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 Manager (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 software reduces turnaround time, eliminates manual
order entry and data reporting, prevents data errors, 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 without 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 instruments 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)
POC
Analyzer
Laboratory, respiratory
or point-of-care locations
Point-of-Care
Data
Manager
Controls any number
of analyzers
HIS
LIS
Laboratory and Hospital
Information Systems
Stat Profile pHOx Series
Specifications
Measured Tests
Methodology
Na+ ............................. Direct ISE
K+ ............................... Direct ISE
Ca++ ............................. Direct ISE
Glucose......................... Enzyme/Amperometric
Lactate.......................... Enzyme/Amperometric
Cl- ................................ Direct ISE
pH ................................ Direct ISE
PCO2 .......................... Severinghaus
PO2 ............................... Amperometric
SO2% ............................ Optical, reflectance
Hematocrit .................. Conductivity/Na+ correction
Hemoglobin ................. Multi-wavelength reflectance/
conductivity correction
Calculated:
TestsResolution
Tests
Resolution
0.1 mmol/L
a/A
0.1
HCO3
TCO2
0.1 mmol/L
PO2/FIO2 0.1
Be-ecf
0.1 mmol/L
Anion Gap 0.1 mmol/L
B-eb
0.1 mmol/L
SBC
0.1 mmol/L
O2Ct
0.1 mL/dL (1 mL/L)
A
0.1 mmHg (0.01 kPa)
A-aDO2 0.1 mmHg (0.01 kPa)
Special Calculated Tests (CO-Oximeter Required):
Tests Resolution
Qsp/Qt 0.1
A-v DO2 0.1 mmHg (0.01 kPa)
CaO2 0.1 mmHg (0.01 kPa)
CcO2 0.1 mmHg (0.01 kPa)
P50
0.1 mmHg (0.01 kPa)
Measurement Range:
Na+ 80 - 200 mmol/L
K+
1 - 20 mmol/L
Ca++ 0.1 - 2.7 mmol/L
Glu 15 - 500 mg/dL
Lac 0.3 - 20 mmol/L
50 - 200 mmol/L
ClpH
6.50 - 8.00 (H+: 316.23 - 10.00 mmol/L)
PCO2 3.0 - 200 mmHg (0.4 - 26.7 kPa)
PO2 0 - 800 mmHg (0.0 - 106.7 kPa)
SO2% 30 - 100 % (0.3 - 1.00)
Hb
4.0 - 24.0 g/dL (2.5 - 14.9 mmol/L)
Hct
12% - 70% (12 - 60% for micro in Plus family
and pHOx Respiratory)
BarP 400.0 - 800.0 mmHg (53.3 -106.7 kPa)
Major Features:
1/4 VGA color display (color available 6/1/05)- multilingual,
visible flow path, automatic QC, QC statistics reports, LeveyJennings plots, gasless calibration (no tanks or regulators),
automatic sampler, integral capillary adapter, PCMCIA type
program changer, optional CCD bar code scanner, single
snap-in reagent system, arterial venous physiological shunt
mode, QC data storage, combined CO-Oximetry and blood gas
results, ventilator settings, draw puncture site
Certifications: ISO 9001 Quality System Registration, CSA,
TÜV, CE Self Declared Complies to EN 61010, EN 50081,82
Physical Specifications: Height: 15.0 in (38.1 cm)
Width: 12.0 in (30.5 cm) Depth: 15.0 in (38.1 cm)
Weight: 18 lb (8.19 kg) without reagent pack
Analytical Specifications for Imprecision
(Normal Aspiration Mode):
Within-Run Imprecision
Day-to-Day Imprecision
n=20 Whichever is Greater
n=20 Whichever is Greater
Analyte
CV%
SD
CV%
SD
1.0 1.0 (mmol/L) 1.5 1.0 (mmol/L)
Na+
K+
1.5 0.15 (mmol/L) 3.0 0.15 (mmol/L)
2.0 0.05 (mmol/L) 4.0 0.05 (mmol/L)
Ca++
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)
1.5 2.0 (mmol/L) 2.5 2.0 (mmol/L)
ClN/A
1.0 %
N/A
1.5 %
SO2%
3.0 1.0 (mmHg) 5.0 2.0 (mmHg)
PCO2
PO2 (< 400 mmHg) 3.0 1.5 (mmHg) 5.0 3.0 (mmHg)
–
10.0
–
PO2 (> 400 mmHg) 6.0
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,
serum plasma (pHOx Plus L only)
Analysis Rate: Stat Analysis Time Throughput Rate
pHOx Basic
45 seconds
50/hour
pHOx Oximetry 45 seconds
50/hour
pHOx Respiratory 52 seconds
40/hour
pHOx Plus
50 seconds
44/hour
pHOx Plus C
52 seconds
44/hour
pHOx Plus L
52 seconds
40/hour
Sample Volume pHOx Basic:
45 microliters whole blood micro sample for pH/PCO2/PO2
70 microliters whole blood sample size for full panel
Sample Volume pHOx Oximetry:
45 microliters whole blood micro sample for blood gases/pH
70 microliters whole blood sample size for full panel
Sample Volume pHOx Respiratory:
60 microliters whole blood micro sample for blood gases/pH
125 microliters whole blood sample size for full panel
Sample Volume pHOx Plus:
55 microliters whole blood micro sample for blood gases/pH
115 microliters whole blood sample size for full panel
Sample Volume pHOx Plus C and pHOx Plus L:
60 microliters whole blood micro sample for blood gases/pH
125 microliters whole blood sample size for 11 test panel
Electrical Requirements: 90-264 VAC, 50/60 Hz, 200W
Interfaces: RS232 serial, ASTM Standard data protocol
Temperature Thermostatting: 37°C ± 0.1°C
Printer: 52 Column thermal — Built in
FDA Labeling: For in-vitro diagnostic use
Calibration: User-selectable, fully automatic two-point
calibration every 2, 4, or 6 hours; user-selectable, single-point
calibration every 30/45 minutes or with each sample (pHOx
Plus and pHOx Plus L are fixed at 30 minutes or with each
sample); manual calibration initiated at any time.
NOVA BIOMEDICAL HEADQUARTERS
200 Prospect Street, Waltham, MA 02454-9141 U.S.A.
TEL: (781) 894-0800 (800) 458-5813 FAX: (781) 894-5915
NOVA BIOMEDICAL AUSTRIA
Laxenburgerstrasse 33/6, 1100 Vienna, Austria
TEL: (43) 1-603 09 700 FAX: (43) 1-603 09 702
NOVA BIOMEDICAL CANADA, LTD
6810 Kitimat Road, Unit 5, Mississauga, Ontario L5N 5M2 Canada
TEL: (905) 567-7700 (800) 263-5999 FAX: (905) 567-5496
NOVA BIOMEDICAL FRANCE
Z.I. de Courtaboeuf, 15 Avenue du Quebec, B.P. 632, 91965
Les Ulis Cedex, France TEL: (33) 1-69188140 FAX: (33) 1-69070160
NOVA BIOMEDICAL GmbH
Adam-Opel-Str. 19 A, D 63322 Rödermark, F.R. Germany
TEL: (49) 6074-8448-0 FAX: (49) 6074-844833
e-mail: [email protected]
NOVA BIOMEDICAL INDIA
117C, Sector-2, Pocket-2, Dwarka, New Delhi 110075 India
TEL: +91 11 2508 9217 +91 11 2508 2664 FAX: +91 11 2508 9018
e-mail: [email protected]
NOVA BIOMEDICAL K.K.
B-3F Omori Bellport, 26-MinamiOi 6-chome,
Shinagawa-ku, Tokyo 140-0013, Japan
TEL: (03) 5471-5461 FAX: (03) 5471-5474
e-mail: [email protected]
NOVA BIOMEDICAL U.K.
C3-5, Evans Business Centre, Deeside Industrial Park,
Deeside, Flintshire CH5 2JZ United Kingdom
TEL: (44) 1244 287087 FAX: (44) 1244 287080
e-mail: offi[email protected]
IN THE U.S., call toll-free 800-458-5813
IN CANADA, call toll-free 800-263-5999
Internet address: www.novabiomedical.com
e-mail: [email protected]
Stat Profile pHOx Series
Co-Oximeter Specifications
Test Menu:
COHb, carboxyhemoglobin; HHb, deoxyhemoglobin;
O 2 Hb, oxyhemoglobin; MetHb, methemoglobin;
tHb, total hemoglobin; SO2%, oxygen saturation; O2Ct,
oxygen content; O2Cap, oxygen capacity
Monitored Interferences:
SulfHb, sulfhemoglobin
(Measured; user alerted if abnormal, > 1.5%)
Sample Volume: 115 µL
Cycle Time: 80 seconds
Samples/Hour: 45
Sample Type: Heparinized whole blood
Operating Ranges:
COHb ..........0 to 100 %
HHb............0 to 100 %
O2Hb............0 to 100 %
MetHb ........0 to 100 %
SO2% ...........0 to 100 %
O2Ct............0 to 40.3 vol%
O2Cap..........0 to 40.3 vol%
tHb..............5 to 30 g/dL
sHb..............Alert > 1.5%
Physical Specifications:
Height 15.0 in (38.1 cm) Width 12.0 in (30.5 cm)
Depth 15.0 in (38.1 cm)
Weight: 18 lb (8.19 kg) without reagent pack
Electrical Power Requirements: 90-264 VAC, 50/60 Hz
Data Ports:
2 bidirectional serial I/O data ports, 1 printer port
1 port for optional external bar code reader
Printer Options:
External, 8-1/2” x 11” dot matrix
External thermal roll printer
Display Languages (user selectable):
English, French, German, Italian, Japanese, and Spanish
Optical System: Spectrophotometer
Wavelengths Measured: 557, 577, 597, 605, 624, 635, 650 nm
Light Source: Halogen
Expected Light Source Use Life: 50,000 Hours (5+ Years)
Cuvette Temperature Control: 37°C ± 0.5°C
Certifications: ISO 9001 Quality System Registration, CSA,
TÜV, CE Self Declared Complies to EN 61010, EN 50081,82
References
National Committee for Clinical Laboratory Standards.
Fractional Oxyhemoglobin, Oxygen Content and Saturation,
and Related Quantities in Blood: Terminology, Measurement
and Reporting. Villanova, PA: NCCLS; 1997.
2
Excessive Blood Drawing for Laboratory Tests. Hicks, J.M.,
The New England Journal of Medicine, May 27, 1999;1690.
3
Evaluation of a new blood-conserving arterial line system for
patients in intensive care units. Silver, M.J., Juhran, H., Stein,
S., et al. Critical Care Medicine, 1993; 21, 507-511.
4
Blood conservation in critical care: the evidence accumulates.
Chernow, B. Critical Care Medicine, 1993; 21, 481-482.
1
Specifications are subject to change without notice. No. 85 3/06