CCX Brochure English

Stat Profile Critical Care Xpress
®
The All-In-One Analyzer
For Blood Gases, CO-Oximetry, Electrolytes,
Chemistry, Hematology and Data Management
More Tests
19 measured and 29 calculated tests
More Models
Thirteen Standard Menus
Small Size
17”x 22”x 17” (44cm x 56cm x 44cm)
Less Work
Automated on-board quality controls
Automated maintenance
Open software architecture
No gas tanks
Stat Profile Critical Care Xpress. The All-In-One Analyzer.
®
More Tests... Less Work... Small Size...
Choice of Test Menus
Stat Profile Critical Care Xpress (CCX) is a
consolidated stat analyzer with up to 19
measured whole blood tests plus 29
calculated tests on board. Thirteen standard
menus provide a choice of popular critical
care assays.
After the desired test menu is chosen,
the user can create custom test panels
which are subsets of that test menu.
Specific test menus can be created for
patient populations such as pulmonary,
surgery, neonatal,or emergency care. It is
not necessary to run the full menu on
every patient.
CCX 1
Blood Gas Only
CCX 2
Blood Gas and CO-Ox
CCX 3
Blood Gas, Lactate and CO-Ox
CCX 4
Blood Gas with Hct, Hb and SO2%
CCX 5
Whole Blood Chem 7 with Hct, Hb
CCX 6
Blood Gas and Electrolytes
CCX 7
Whole Blood Chem 8 with Hct, Hb
CCX 8
Critical Care Chemistries
CCX 9
Blood Gas with Whole Blood Chem 7 and Hct, Hb
CCX 10
Blood Gas with Whole Blood Chem 8 and Hct, Hb
CCX 11
Blood Gas and Critical Care Chemistries
CCX 12
Full Critical Care Profile
CCX 13
Full Critical Care Profile with CO-Ox
2
3
Stat Profile Critical Care Xpress. The All-In-One Analyzer.
®
A Selection Guide for Models, Tests, Operating
and Stat Analysis Times
Model & Name
Test Menu
Sample
Volume(µL)
CCX 1
Blood Gas Only
1. pH, PCO2, PO2
150
CCX 2
Blood Gas and CO-Ox
1. pH, PCO2, PO2, CO-Ox
210
CCX 3
Blood Gas, Lactate and CO-Ox
1. pH, PCO2, PO2, Lac and CO-Ox
210
CCX 4
Blood Gas with Hct, Hb & SO2%
1. pH, PCO2, PO2, SO2%, Hct, Hb
150
1. Na+, K+, Cl-, Glu, BUN, Creat, TCO2 (calc.), Hct, Hb
2. Full CCX 5 Menu except Creat
150
150
1. pH, PCO2, PO2, Na+, K+, Cl-, Ca++, Mg++, Hct, Hb
2. Full CCX 6 Menu except Mg++
150
150
1. Na+, K+, Cl-, Ca++, Glu, BUN, Creat, TCO2 (calc.), Hct, Hb
2. Full CCX 7 Menu except Creat
150
150
1. Na+, K+, Cl-, Ca++, Mg++, Glu, BUN, Creat, Lac, Hct, Hb
2. Full CCX Menu except Creat/Mg++
150
150
1. pH, PO2, PCO2, Na+, K+, Cl-, Glu, BUN, Creat, TCO2 (calc.), Hct, Hb
2. Full CCX 9 Menu except Creat
150
150
1. pH, PO2, PCO2, Na+, K+, Cl-, Ca++, Glu, BUN, Creat, TCO2 (calc.), Hct, Hb
2. Full CCX 10 Menu except Creat
150
150
1. pH, PO2, PCO2, Na+, K+, Cl-, Ca++, Mg++, Glu, BUN, Creat, Lac, Hct, Hb
2. Full CCX 11 Menu except Mg++/Creat
150
150
1. pH, PO2, PCO2, SO2%, Na+, K+, Cl-, Ca++, Mg++, Glu, BUN, Creat, Lac, Hct, Hb,
2. Full CCX 12 Menu except Mg++/Creat
150
150
1. pH, PO2, PCO2, SO2%, Na+, K+, Cl-, Ca++, Mg++, Glu, BUN, Creat, Lac, Hct, Hb, CO-Ox
2. Full CCX 13 Menu except Mg++/Creat
210
210
CCX 5
Whole Blood Chem 7 with Hct, Hb
CCX 6
Blood Gas and Electrolytes
CCX 7
Whole Blood Chem 8 with Hct, Hb
CCX 8
Critical Care Chemistries
CCX 9
Blood Gas with Whole Blood Chem 7 and Hct, Hb
CCX 10
Blood Gas with Whole Blood Chem 8 and Hct, Hb
CCX 11
Blood Gas and Critical Care Chemistries
CCX 12
Full Critical Care Profile
CCX 13
Full Critical Care Profile with CO-Ox
Stat Profile CCX is a series of thirteen models of whole blood critical care analyzers ranging from a three test blood gas menu to a
nineteen measured test menu including CO-Oximetry. Any of these
basic menus can be further customized by adding or deleting tests.
After selecting a desired test menu, custom test panels can be
created. For example, a blood gas only or chemistry only panel
can be created and run as an option to the full test menu.
The CO-Oximetry test menu listed above includes measured HHb,
O2Hb, MetHb, COHb, tHb, SO2%, O2Ct, and O2Cap.
4
g Modes, Sample Volumes,
Microsample Mode
Normal Mode
Analysis Time Samples/Hour
(seconds)
Nanosample Mode
Sample
Volume(µL)
Analysis Time
(seconds)
Samples/Hour
60
72
30
1. pH, PCO2, PO2
60
72
30
Test Menu
Sample
Volume(µL)
Analysis Time
(seconds)
Samples/Hour
50
36
61
32
No
Microsample
Mode
No
Microsample
Mode
No
Microsample
Mode
1. pH, PCO2, PO2
60
72
30
61
32
No
Microsample
Mode
No
Microsample
Mode
No
Microsample
Mode
1. pH, PCO2, PO2, Lac
70
85
26
50
36
110
89
26
1. pH, PCO2, PO2, SO2%, Hct, Hb
70
85
26
123
50
24
36
110
110
157
89
21
26
1. Na+, K+, Cl-, Ca++, Glu, Hct, Hb
70
85
28
123
50
24
36
110
110
157
89
21
26
1. Na+, K+, Cl-, Ca++, pH, Hct, Hb
2. pH, PCO2, PO2
70
60
85
72
26
30
123
50
24
36
110
110
157
89
21
26
1. Na+, K+, Cl-, Ca++, Glu, Hct, Hb
70
85
26
123
50
24
36
110
110
157
89
21
26
1. Na+, K+, Cl-, Ca++, Glu, Lac, Hct, Hb
70
85
28
123
50
24
36
110
110
157
89
21
26
1. Na+, K+, Cl-, pH, Glu
2. pH, PCO2, PO2, Hct, Hb, Glu
70
70
85
85
28
28
123
50
24
36
110
110
157
89
21
26
1. Na+, K+, Cl-, Ca++, pH, Glu, Hct, Hb 70
70
2. pH, PCO2, PO2, Glu, Hct, Hb
85
85
28
28
123
50
24
36
110
110
157
89
21
26
1. Na+, K+, Cl-, Ca++, pH, Glu, Lac, Hct, Hb 70
70
2. pH, PCO2, PO2, Hct, Hb
85
85
28
28
123
50
24
36
110
110
157
89
21
26
1. Na+, K+, Cl-, Ca++, pH, Glu, Lac,Hct,Hb 70
2. pH, PCO2, PO2, SO2%, Glu, Lac, Hct, Hb70
85
85
28
28
134
61
22
32
110
110
157
89
21
26
1. Na+,K+,Cl-,Ca++, pH,Glu, Lac, Hct, Hb 70
2. pH, PCO2, PO2, SO2%, Hct, Hb
70
85
85
28
28
5
6
Stat Profile Critical Care Xpress. The All-In-One Analyzer.
®
More Tests... Less Work... Small Size...
Color Touch Screen Operation
Critical Care Xpress features a large
(10”) color touch screen interface with
intuitive, prompted operation. Screens
can be user-defined, based on the sitespecific work flow and needs of the user.
Automated, On-Board QC
Eliminates Labor;
Assures Compliance
For most users, analyzing controls and
entering QC data require more time and
labor than any other aspect of blood gas
testing. The automated, on-board QC
system on the Critical Care Xpress
eliminates the steps involved in manually
performing quality control, thereby
dramatically reducing labor costs.
• Snap-in, tri-level QC packs are on board
the instrument and are programmed to
be analyzed at preset times.
• QC data is automatically stored.
• If an auto QC fails, an optional
instrument lockout is available.
• Audible alarms and auto-paging
for QC failure are options.
• QC data can be transmitted electronically
to Nova’s Peer Group Comparison Program.
SmartCheck Automated
Maintenance
SmartCheck allows the operator to initiate
maintenance on the touch screen and then
walk away from the analyzer. Priming,
calibration, and quality control are all
performed automatically and correctly.
SmartCheck software not only frees the
operator from performing maintenance, it
is fast. It reduces system down time by up
to one hour, compared to other analyzers.
No Gas Tanks
An innovative, liquid-only calibration
system eliminates bulky compressed gas
tanks, gas regulators, gas tubing lines, and
humidifiers. Instead, a single, snap-in
reagent pack contains all required liquid
and gas calibrators. The reagent pack
includes a sealed waste container that
stores sample and reagent waste.
Integrated, On-Board CO-Oximeter
For those applications requiring a more
comprehensive hemoglobin profile than
measured hematocrit, hemoglobin, and
SO 2%, Critical Care Xpress offers
integrated, on-board CO-Oximetry. The
CO-Oximeter offers a combination of
eight measured and calculated hemoglobin
and oxygen transport tests, including
deoxyhemoglobin (HHb), oxyhemoglobin
(O2Hb), methemoglobin (MetHb), and
carboxyhemoglobin (COHb).
Small Sample Volume
Blood conservation is an important
initiative in every critical care department.
Critical Care Xpress promotes reduced
blood usage in both full panel and micro
modes. Blood gases can be performed
on as little as 50 microliters of whole
blood, while a full 19 test panel requires
only 210 microliters of sample. These
are the smallest sample volumes
available for these tests.
Best Performing Biosensors
Nova Biomedical is the world leader in the
development of electrode-based biosensor
technology. For the past 27 years, Nova has
developed and pioneered more whole
blood sensors than any other company. The
reliability, accuracy, and long life of our
sensors are unsurpassed.
Smallest Analyzer
Although Critical Care Xpress incorporates
more on-board tests than any other critical
care analyzer, it is elegantly designed with
an overall size of only 17”H x 22”W x 17”D
(3.35 cubic feet) and a footprint of just
2.5 square feet. It is 20-40% smaller than
comparable instruments and is easily
transported on its mobile cart. A single,
snap-in reagent pack eliminates bulky
gas tanks, regulators, and humidifiers,
as well as the large number of calibrating
and cleaning solution bottles used in
other analyzers.
7
Stat Profile Critical Care Xpress. The All-In-One Analyzer.
®
Advanced Data Management Software
Open Software Architecture
Allows Custom Configuration
of Analyzer Operation
The flexible software designed into
Critical Care Xpress allows the user to
customize a wide range of instrument
operating protocols, touch screen
layouts, report formats, security
options, QC processes, and data
management capabilities. More than
any other analyzer, Critical Care Xpress
allows custom configuration to meet
your exact requirements. Some examples
of user choices are:
• Customize up to 30 test panels
• Define test ranges by age and sex
• Customize patient data fields and
sample data fields
• Specify mandatory (required)
data fields
• Set default settings for data fields
• Customize patient report formats
• Customize touch screen layouts
• Select screen sequences
• Customize data entry methods
• Individually define password privileges
• Customize on-board, automated QC
procedures
Customized Test Panel
8
Integrated On-Board Data Management
Patient Trend Report
All Critical Care Xpress analyzers have
on-board data management software,
allowing data capture, manipulation,
and reporting. Some features are:
• Automatic entry of patient
demographics for repeat testing
• Simple entry of data by bar code,
default, touch screen, or integrated
keyboard
• On-board storage and retrieval of patient
results, QC , demographics,
maintenance, and authorized users
• Sort by name, ID, date or location
• Bidirectional host query for patient
demographics
• Complete management reporting:
- Patient Trend Reports
- Action (Panic) Logs
- Operator Logs
- Levey-Jennings QC Reports
- QC Exceptions Report
- Feedback Event Log
- RTM Setup Report
- Daily Patient Data Log
- Rejected Results Report
- Patient Information
- Panic and Reference Range Report
- Preventive Maintenance Log
- Daily Calibration Data Log
- Daily Quality Control Data Log
- QAP Report (Monthly Statistics)
- QC Cumulative Control Statistics
- Quality Control Setup Report
Point-of-Care Manager
Advanced Software & Connectivity
Comprehensive Remote Control
and Review
In hospitals with multiple critical care
analyzers, the need to monitor and control
the data from these analyzers becomes as
important as the tests themselves. Critical
Care Xpress can interface with Nova’s
Point-of-Care Manager software to:
• Restrict analyzer access with password
identification
• Allow analyzer shutdown if auto QC fails
• Enable or disable tests and operator
password privileges
• Remotely perform QC cycles,
instrument calibrations,
and flush cycles
• Remotely review and
diagnose CCX status
• Manage multiple analyzers
from a single location
• Preview results before
releasing to POC
Advanced Connectivity
Options
Critical Care Xpress is compliant with the new NCCLS/IFCC
“plug and play” connectivity
standards and is compatible
with a wide array of connectivity platforms and devices that
use ASTM or HL7 protocols via
serial or TCP/IP connections
including:
• Connectivity platforms
- LAN
- Modem
- Internet
- Wireless
• Connectivity devices
- Hand-held data receivers
- Remote monitors/printers
- LIS, HIS
- Data manager
Complete Process Automation
Once a patient identifier is entered into the
analyzer, the Point-of-Care Manager automates the order entry, accessioning, and
reporting process. By reducing the
number of “touches” required to perform
POC testing, this process automation
feature reduces turnaround time,eliminates
manual order entry and data reporting,
prevents data errors,and improves
efficiency of operation.
9
Stat Profile Critical Care Xpress. The All-In-One Analyzer.
®
Stat Profile Critical Care Xpress Specifications
®
Critical Care Test Menu:
pH ................................
PCO2 ..............................
PO2 ...............................
SO2% ..............................
Hematocrit ...................
Hemoglobin ..................
Na+ ...............................
K+ .................................
Cl- .................................
Ca++ ..............................
Mg++..............................
Glucose..........................
BUN...............................
Creatinine.....................
Lactate...........................
Methodology:
Direct ISE
Severinghaus
Amperometric
Optical, reflectance
Conductivity/Na+ correction
Multi-wavelength reflectance/
conductivity correction
Direct ISE
Direct ISE
Direct ISE
Direct ISE
Direct ISE
Enzyme/Amperometric
Enzyme/Direct ISE
Enzyme/Amperometric
Enzyme/Amperometric
Calculated Tests:
HCO3a/A
Ca++/Mg++ Ratio
TCO2
PO2/FIO2
Normalized Ca++
BE-ecf
Anion Gap
Normalized Mg++
BE-b
SBC
Osmolality
O2Ct
Base Excess
O2 Cap
A
O2 Saturation
Hemoglobin
A-aDO2
BUN/Creatinine Ratio
pH/PCO2/PO2 Corrected to Patient Temperature
Respiratory Index, (If % FIO2 value entered)
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)
C(a-v)O2
0.1 mmHg (0.001 kPa)
Complete Management Reports:
- Patient Trend Reports
- Action (Panic) Logs
- Operator Logs
- Levey-Jennings QC Reports
- QC Exceptions Report
- Feedback Event Log
- RTM Setup Report
- Daily Patient Data Log
- Rejected Results Report
- Patient Information
- Panic and Reference Range Report
- Preventive Maintenance Log
- Daily Calibration Data Log
- Daily Quality Control Data Log
- QAP Report (Monthly Statistics)
- Quality Control Cumulative Control Statistics
- Quality Control Setup Report
CO-Oximetry Test Menu:
HHb, deoxyhemoglobin
O2Hb, oxyhemoglobin
MetHb, methemoglobin
COHb, carboxyhemoglobin
tHb, total hemoglobin
SO2 %, oxygen saturation
O2 Ct, oxygen content
O2Cap, oxygen capacity
10
Monitored Interferences:
sHb, sulfhemoglobin
(Measured; user alerted if abnormal, > 1.5%)
Measurement Range:
pH
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)
Hct
12% - 70%
Hb
4.0 - 24.0 g/dL (2.5 - 14.9 mmol/L)
Na+
80 - 200 mmol/L
K+
1 - 20 mmol/L
Cl50 - 200 mmol/L
Ca++
0.1 - 2.7 mmol/L
Mg++
0.1- 1.5 mmol/L
Glucose
15 - 500 mg/dL
BUN
3 - 100 mg/dL
Creatinine 0.2 -20 mg/dL
Lactate
0.3 - 20 mmol/L
HHb
0 to 100%
O2Hb
0 to 100%
MetHb
0 to 100%
COHb
0 to 100%
SO2%
0 to 100%
O2Ct
0 to 34.75 vol. %
O2Cap
0 to 34.75 vol. %
tHb
5 - 30 g/dL
sHb
Alert > 1.5%
BarP
400.0 - 800.0 mmHg (53.3 -106.7 kPa)
Typical Analytical Specifications for Imprecision:
Within-Run Imprecision
n=20 Whichever is Greater
Analyte
pH
PCO2
PO2
SO2%
Hct
Hb
Na+
K+
ClCa++
Mg++
Glucose
BUN
Creatinine
CV%
N/A
3.0
3.0
N/A
N/A
2.5
1.0
1.5
1.5
2.0
2.0
3.0
3.0
3.0
SD
0.005
1.0 (mmHg)
2.0 (mmHg)
1.0 %
1.0 %
0.3 g/dL
1.0 (mmol/L)
0.15 (mmol/L)
2.0 (mmol/L)
0.05 (mmol/L)
0.03 (mmol/L)
2.0 (mg/dL)
0.8 (mg/dL)
0.13 (mg/dL)
Lactate
tHb
O2Hb
COHb
MetHb
HHb
3.0 0.3 (mmol/L)
3.0
3.0
3.0
3.0
3.0
Day-to-Day Imprecision
n=20 Whichever is Greater
CV%
SD
N/A
0.013
5.0 2.0 (mmHg)
5.0 3.0 (mmHg)
N/A
1.5 %
N/A
1.5 Hct%
3.0
0.5 g/dL
2.0 1.5(mmol/L)
3.0 0.2 (mmol/L)
2.5 3.0(mmol/L)
4.0 0.07 (mmol/L)
4.0 0.05 (mmol/L)
5.0 3.0 (mg/dL)
5.0 3.0 (mg/dL)
7.0 0.2 (mg/dL)
10.0 (If >10 mg/dL)
6.0 0.5 (mmol/L)
4.5
0.6 (g/dL)
3.0
0.8 (%)
3.0
0.8 (%)
3.0
0.8 (%)
4.5
0.8 (%)
Languages Currently Available:
English, German, French, Spanish
Languages Under Development:
Italian, Japanese, Chinese, Turkish, Russian,
Swedish, Korean, Greek
Major Features:
Full color, 10.5 inch touch screen, multilingual, automatic
liquid calibration, QC statistics, on-board data management,
automatic on-board controls, automatic sampler, integrated
capillary adapter, optional bar code scanner, QC data
storage, ASTM and HL7 communication protocols, optional
mobile cart with UPS
Certifications:
ISO 9001 Quality System Registration, CSA,
TÜV, CE Self Declared Complies to EN 61010, EN 50081,82
Typical Sample Volume:
50 microliters whole blood micro sample for blood gases/pH
110 microliters micro sample for full panel without CO-Oximetry
150 microliters whole blood sample for full panel without
CO-Oximetry
210 microliters whole blood sample for full panel with CO-Oximetry
Physical Specifications:
Height: 17.22 in (43.7 cm) Width: 22.34 in (56.7 cm)
Depth: 17.26 in (43.8 cm) Weight: 53 lb without reagent pack
Electrical Power Requirements:
90-264 VAC, 50/60 Hz, 350 W
Interfaces:
RS232 serial communication and HL7 ASTM Standard data
protocols, HL7 on TCP/IP, USB ports
Temperature Thermostatting:
37°C ± 0.1°C
Printer:
80 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 minutes or with each sample. Manual calibration initiated
at any time.
Acceptable Samples:
Whole blood (heparinized), serum/plasma, arterial,
mixed venous, capillary
Analysis Rate:
Mode A:
Mode B:
Mode C:
Stat Analysis Time Throughput Time
62 seconds
38 samples/hr
134 seconds
23 samples/hr
62 seconds
38 samples/hr
11
Stat Profile pHOx Series
®
®
Stat Profile pHOx is a series of six moderately priced blood gas/critical care analyzers. They
are designed for departments that do not need the breadth of test menus offered by the Stat
Profile CCX series. Contact us for more detailed information.
Stat Profile pHOx Basic
Stat Profile pHOx Blood Gas/Oximetry Profile
Stat Profile pHOx Plus Critical Care Profile
Stat Profile pHOx Plus C Critical Care Profile
Stat Profile pHOx Plus L Critical Care Profile with Lactate
Stat Profile pHOx CO-Oximeter
Nova Electrolyte/Chemistry Analyers
Nova Electrolyte/Chemistry analyzers can use whole blood, plasma, serum, or urine as samples.
Each analyzer can be used as either a single sample stat analyzer or as a 40-position turntable,
automated analyzer.
Nova 1
Nova 4
Nova 5
Nova 8
Nova 10
Nova 11
Nova 12
Nova 13
Nova 14
Nova 16
NOVA BIOMEDICAL HEADQUARTERS 200 Prospect Street, Waltham, MA 02454-9141 U.S.A. TEL: (781) 894-0800 (800) 458-5813 FAX: (781) 894-5915 Int’l FAX: (781) 899-0417
NOVA BIOMEDICAL AUSTRIA/EASTERN EUROPE/MIDDLE EAST 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 K.K. Avenue Takanawa 405, 3-25-27 Takanawa, Minato-ku, Tokyo 108, Japan TEL: (81) 3-3473-9641 FAX: (81) 3-5791-7012
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: [email protected]
IN THE U.S.A., call toll-free 800-458-5813
IN CANADA, call toll-free 800-263-5999
www.novabiomedical.com
Specifications are subject to change without notice. No 127 1/04