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CORPORATE DESCRIPTION: Nova Biomedical is the world leader in whole blood biosensor technology. Nova's menu of nineteen measured tests is the largest available from any manufacturer. No other company has as many whole blood assays. No other company has been first in developing as many biosensor assays.

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Instrument Stat Profile® Critical Care Xpress

Size:

17.2 in (43.7 cm) Height
22.3 in (56.7 cm) Width
17.3 in (43.8 cm) Depth

Data Transfer Capability: RS232 serial communication, HL7 & ASTM Standard data protocols, ASTM & HL7 on TCP/IP, USB ports

Specifications:

Test Menu: pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Cl-, iCa, iMg, Glucose, BUN, Creatinine, Lactate, HHb, O2Hb, MetHb, COHb

CPT codes:

• 82800 - Blood Gases

• 82790 - Oxygen Saturation

• 84295 - Sodium (Na)

• 84132 - Potassium (K)

• 82435 - Chloride (Cl)

• 82330 - Ionized Calcium (iCa)

• 83735 - Ionized Magnesium (iMg)

• 82947 - Glucose (Glu)

• 84520 - Urea Nitrogen, Blood (BUN)

• 82565 - Creatinine (Crea)

• 83605 - Lactate (Lac)

• 85014 - Hematocrit (Hct)

• 85018 - Hemoglobin (Hb)

• N/A- CO-Oximetry

Test Methodology: Direct ISE, amperometric, conductivity and optical reflectance

Units in which test result is reported:

• Blood Gases pH units, mmHg or kPa

• Oxygen Saturation %

• Sodium (Na) mmol/L, mEq/L

• Potassium (K) mmol/L, mEq/L

• Chloride (Cl) mmol/L

• Ionized Calcium (iCa) mmol/L, mg/dL

• Ionized Magnesium (iMg) mmol/L, mg/dL

• Glucose (Glu) mmol/L, mg/dL

• Urea Nitrogen, Blood (BUN) mmol/L, mg/dL

• Creatinine (Crea) mg/dL, mmol/L

• Lactate (Lac) mmol/L

• Hematocrit (Hct) %

• Hemoglobin (Hb) mmol/L, g/dL

• CO-Oximetry %

Sample Volume:

• 50 microliters whole blood micro sample for blood gases/pH

• 100 microliters micro sample for full panel without co-oximetry

• 150 microliters whole blood sample for full panel without co-oximetry

• 200 microliters micro sample for full panel with co-oximetry

Time to result:

• 65 seconds (high throughput)

• 140 seconds (routine throughput)

CLIA Classification: Moderately complex

Other:

1. Measures up to 19 tests on a single analyzer
2. 29 calculated tests on-board
3. Seven standard menus plus unlimited custom tests menus
4. Integrated, on-board co-oximeter
5. On-board Windows 2000 data management system
6. Economical, long life microsensors
7. Simple operation using a user configurable touch screen
8. All liquid calibration system eliminates gas tanks
9. Automated, on-board QC eliminates labor and assures compliance
10. SmartCheck automated maintenance system
11. Automatic sampling from syringes, capillaries, and open tubes
12. CIC compliant with advanced connectivity

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Instrument Stat Profile pHOx® Basic

Size:

• 15 in (38.1 cm) Height

• 12 in (30.5 cm) Width

• 15 in (38.1 cm) Depth

Data Transfer Capability: RS232 serial communications, direct interface capability, ASTM , LAN connection (optional)

Specifications:

Test Menu: pH, PCO2, PO2

CPT codes:

• 82800 - Blood Gases

Test Methodology: Direct ISE, amperometric, conductivity and optical reflectance

Units in which test result is reported:

• Blood Gases pH units, mmHg or kPa

Sample Volume:

• 45 microliters whole blood microsample for blood gases/pH

• 70 microliters whole blood sample for full panel

Time to result: 45 seconds

CLIA Classification: Moderately complex

Other:

1. Three-test analyzer is perfect for blood gas instrument replacement
2. All liquid calibration cartridge eliminates the need for gas tanks and contains all solutions required for operation
3. On-board cartridge QC automates quality control
4. Compact POCT design
5. Easy, safe capillary or syringe use
6. Can be interfaced with Nova Remote Testing Manager connectivity software

7. CO-Oximeter module available

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Size:

• 15 in (38.1 cm) Height

• 12 in (30.5 cm) Width

• 15 in (38.1 cm) Depth

Data Transfer Capability: RS232 serial communications, direct interface capability, ASTM, LAN connection (optional)

Specifications:

Test Menu: pH, PCO2, PO2, SO2%, Hct, Hb

CPT codes:

• 82800 - Blood Gases

• 82790 - Oxygen Saturation

• 85014 - Hematocrit (Hct)

• 85018 - Hemoglobin (Hb)

Test Methodology: Direct ISE, amperometric, conductivity and optical reflectance

Units in which test result is reported:

• Blood Gases pH units, mmHg or kPa

• Oxygen Saturation %

• Hematocrit (Hct) %

• Hemoglobin (Hb) mmol/L, g/dL

Sample Volume:

• 45 microliters whole blood microsample for blood gases/pH

• 70 microliters whole blood sample for full panel

Time to result: 45 seconds

CLIA Classification: Moderately complex

Other:

1. Six-test analyzer is perfect for blood gas instrument replacement

2. Provides blood gas results with a co-oximetry panel for a complete oxygenation picture.

3. All liquid calibration cartridge eliminates the need for gas tanks and contains all solutions required for operation

4. On-board cartridge QC automates quality control

5. Compact POCT design

6. Easy, safe capillary or syringe use

7. Can be interfaced with Nova Remote Testing Manager (PDM) connectivity software

8. CO-Oximeter module available

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Size:

• 15 in (38.1 cm) Height

• 12 in (30.5 cm) Width

• 15 in (38.1 cm) Depth

Data Transfer Capability: RS232 serial communications, direct interface capability, ASTM, LAN connection (optional)

Specifications:

Test Menu: pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Glucose, Ca++ or Cl-

CPT codes:

Test Methodology: Direct ISE, amperometric, conductivity and optical reflectance

Units in which test result is reported:

• Blood Gases pH units, mmHg or kPa

• Oxygen Saturation %

• Hematocrit (Hct) %

• Hemoglobin (Hb) mmol/L, g/dL

• Sodium (Na+), Potassium (K+), Calcium (Ca++), Chloride (Cl-) mmol/L

• Glucose (Glu) mmol/L

Sample Volume:

• 55 microliters whole blood microsample for blood gases/pH

• 115 microliters whole blood sample for full panel

Time to result: 50 seconds

CLIA Classification: Moderately complex

Other:

1. Ten-test analyzer ideal for critical care

2. Provides blood gas results with an oximetry panel for a complete oxygenation picture

3. All liquid calibration cartridge eliminates the need for gas tanks and contains all solutions required for operation

4. On-board cartridge QC automates quality control

5. Compact POCT design

6. Easy,safe capillary or syringe use

7. Can be interfaced with Nova Remote Testing Manager connectivity software

8. CO-Oximeter module available

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Instrument Stat Profile pHOx® Plus C

Size:

• 15 in (38.1 cm) Height

• 12 in (30.5 cm) Width

• 15 in (38.1 cm) Depth

Data Transfer Capability: RS232 serial communications, direct interface capability, ASTM, LAN connection (optional)

Specifications:

Test Menu: pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Glucose, Ca++, Cl-

CPT codes:

Test Methodology: Direct ISE, amperometric, conductivity and optical reflectance

Units in which test result is reported:

• Blood Gases pH units, mmHg or kPa

• Oxygen Saturation %

• Hematocrit (Hct) %

• Hemoglobin (Hb) mmol/L, g/dL

• Sodium (Na+), Potassium (K+), Calcium (Ca++), Chloride (Cl-) mmol/L

• Glucose (Glu) mmol/L

Sample Volume:

• 60 microliters whole blood microsample for blood gases/pH

• 125 microliters whole blood sample for full panel

Time to result: 52 seconds

CLIA Classification: Moderately complex

Other:

1. Eleven-test analyzer ideal for critical care

2. Provides blood gas results with an oximetry panel for a complete oxygenation picture

3. All liquid calibration cartridge eliminates the need for gas tanks and contains all solutions required for operation

4. On-board cartridge QC automates quality control

5. Compact POCT design

6. Easy,safe capillary or syringe use

7. Can be interfaced with Nova Remote Testing Manager connectivity software

8. CO-Oximeter module available

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Instrument Stat Profile pHOx® Plus L

Size:

• 15 in (38.1 cm) Height

• 12 in (30.5 cm) Width

• 15 in (38.1 cm) Depth

Data Transfer Capability: RS232 serial communications, direct interface capability, ASTM, LAN connection (optional)

Specifications:

Test Menu: pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Glucose, Ca++ or Cl-, Lactate

CPT codes:

Test Methodology: Direct ISE, amperometric, conductivity and optical reflectance

Units in which test result is reported:

• Blood Gases pH units, mmHg or kPa

• Oxygen Saturation %

• Hematocrit (Hct) %

• Hemoglobin (Hb) mmol/L, g/dL

• Sodium (Na+), Potassium (K+), Calcium (Ca++), Chloride (Cl-) mmol/L

• Glucose (Glu), Lactate (Lac) mmol/L

Sample Volume:

• 60 microliters whole blood microsample for blood gases/pH

• 115 microliters whole blood sample for full panel

Time to result: 52 seconds

CLIA Classification: Moderately complex

Other:

1. Eleven-test analyzer ideal for critical care

2. Provides blood gas results with an oximetry panel for a complete oxygenation picture.

3. All liquid calibration cartridge eliminates the need for gas tanks and contains all solutions required for operation

4. On-board cartridge QC automates quality control

5. Compact POCT design

6. Easy,safe capillary or syringe use

7. Can be interfaced with Nova Remote Testing Manager connectivity software

8. CO-Oximeter module available

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Instrument Nova 16

Size:

• 20.5 in (52.1 cm) Height

• 19.2 in (48.8 cm) Width

• 20.7 in (52.6 cm) Depth

Data Transfer Capability: RS232 serial communication, ASTM bi-directional, direct interface capability, LAN connection (optional)

Specifications:

Test Menu: Na+, K+, Cl-, TCO2, Glucose, BUN, Creatinine, Hct

CPT codes:

• 84295 - Sodium (Na)

• 84132 - Potassium (K)

• 82435 - Chloride (Cl)

• 82947 - Glucose (Glu)

• 84520 - Urea Nitrogen, Blood (BUN)

• 82565 - Creatinine (Crea)

• 85014 - Hematocrit (Hct)

• 82374 - Total CO2 (TCO2)

Test Methodology: Direct ISE, amperometric, conductivity

Units in which test result is reported:

• Sodium (Na) mmol/L, mEq/L

• Potassium (K) mmol/L, mEq/L

• Chloride (Cl) mmol/L

• Glucose (Glu) mmol/L, mg/dL

• Urea Nitrogen, Blood (BUN) mmol/L, mg/dL

• Creatinine (Crea) mg/dL, mmol/L

• Hematocrit (Hct) %

• Total CO2 (TCO2) mmol/L

Sample Volume: 385 microliters

Time to result: 85 seconds

CLIA Classification: Moderately complex

Other:

1. Measures the 7 most commonly ordered tests on a single analyzer
2. First and only analyzer to measure Creatinine and TCO2 on whole blood
3. Automation of POCT process (optional)
4. Password protection
5. Quality Control Reminder and Lockout
6. Remote Review and Remote Supervision from centralized location
7. First and only whole blood Chem 7 analyzer
8. On board QC
9. Nova 16 placed at the POC can be interfaced to a single Patient Data Manager to provide automated test ordering and reporting through a laboratory information system

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The most comprehensive blood gas and critical care data management system in the industry.  This advanced clinical workstation is designed to seamlessly manage stat testing, reporting, and CLIA documentation.

• Allows multiple Nova analyzers to be monitored from a single workstation located anywhere

• Captures all patient results and data from each remote analyzer,

• Captures all calibrations, QC data, reagent status, operator identification, system status, and diagnostic information. 

Device Control: The PDM manages multiple analyzers, maintains QC and maintenance records, and automatically flags and logs abnormal results.

Remote Control: Allows the lab to initiate an automated analyzer calibration, maintenance cycle, or on-board QC testing.  Restricts analyzer use by password access, and permits the lab to enable or disable any test channel on the analyzer.

Remote Review: Enables the central laboratory to have a constant overview of 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.

Quality Control: Maintains QC records for all lots and devices, and generates comprehensive patient, CLIA, and QC reports. Generates Levey-Jennings QC graphs, enables Westgard rules, and automatically compiles analyzer QC data for Nova’s monthly peer group Quality Assurance Program.

Operator Control: Multi-level password protection for complete data security.  Mandatory log-on, data verification, initialed reports, and a comprehensive backup and archival system guarantee confidentiality and security for all data. Maintains “certification” records and alerts management to certification status. 

Patient Data: All patient data are can automatically imported, checked, and stored in the PDM on-line database.  Abnormal patient test results are automatically flagged, and panic results are logged along with the name of the individual notified and time of notification.  All data can be sent to the hospital or departmental information system for charting or billing purposes. 

Information Distribution: Provides a mechanism to prepare a wide range of standard patient, CLIA, and QC reports. Interfaces with an array of output devices including monitors, printers, pagers, and clinical information systems, and can be seamlessly integrated into a client server network.

LIS Compatibility: Provides a bi-directional connection with an LIS or HIS via either ASTM or HL7 interface formats. When used in conjunction with a third party data management system, a single PDM will interface with analyzers from multiple POC vendors. PDM software is compliant with the CIC NCCLS-POCT1-A standard interface.

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Last updated:  03/20/2003
Questions or corrections:  Webmaster
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