Nova Biomedical- Hospital Based Blood Gas and Critical Care Analyzers
Hospital Connectivity Glucose Measuring System






Nova Biomedical- Hospital Based Blood Gas and Critical Care Analyzers
Hospital Connectivity Glucose Measuring System

Only glucose meters accurate enough to be FDA-cleared for use with ALL patients


CLIA waived for use with arterial, venous, and capillary samples from critically ill patients


ONLY glucose meter with no known clinical interferences—over 8,000 medications tested

• Measures and corrects for interferences, which cause incorrect glucose readings and patient mismanagement

Proven safety and accuracy
• In one study of over 17,300 capillary results from critically ill patients
• In another study of 1,698 arterial and venous results from critically ill patients with over 257 medical conditions
• Improved accuracy results in less insulin misdosing and better outcomes for critically ill patients

Hospitals using StatStrip do not need to define “critically ill” and develop alternative testing process

Use of any other meter with critically ill patients is considered off label by the FDA and high complexity testing under CLIA, regardless of sample type

Read Nova’s 2018 press release for StatStrip’s capillary critical care clearance here

Read the FDA’s 2014 press release for StatStrip’s critical care clearance here

Read Nova’s 2014 press release for StatStrip here

Use of any other glucose meter with critically ill patients is off label

StatStrip is FDA cleared and CLIA waived for use throughout all hospital and all professional healthcare settings including critical care. Use of any other glucose meter with critically ill patients is considered off label by the FDA and high complexity testing under CLIA, regardless of sample type.

The personnel testing requirements for off-label use are very demanding and limit who can perform testing. In addition, a hospital must conduct comprehensive validation testing to prove that off-label use of the meter is safe and effective over the range of complex medical conditions found in critically ill patients and intensive care units.

World’s most extensively studied and proven glucose measurement technology

In addition to the study submitted to the FDA, 138 other independent studies over the last eight years—including 53 critical care studies—have found no clinically significant interferences for StatStrip. This is a statement that no other glucose meter manufacturer can make.

Download a bibliography of publications here

Learn More

To learn more about how StatStrip can help hospitals avoid the risk of glucose meter off-label use and bring critical care testing to the bedside, contact your current GPO, call Nova at 800-458-5813, or CONTACT US HERE






Dimensions:

Weight: 0.49 lb (220 g)
Size: 5.8 in x 3.1 in x 1.18 in
(147 mm x 79 mm x 30 mm)

Data Storage:

Patient Tests: 1,000 tests
QC Tests: 200 tests
Users: 4,000 users

Connectivity:

Meter Data Output: RJ-45 Ethernet Port
Protocol: TCP/IP Ethernet 10 Mbit
Standard: POCT1-A2 Compliant
Setup Program: NovaNet Web-Based Instrument Manager Software

Battery Information:

Type: 3.7V Li Polymer Rechargeable Battery
Features: Rechargeable/Replaceable
Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby

Docking Station:

Optional accessory; desk or wall mount charging station with RJ-45 Ethernet jack. 3 LED indicator lights showing connection status, transmit/receive data, and charging status. Extra battery slot included for recharging and storage of spare battery.

Additional Features:

  • • Color touchscreen
  • • Built-in barcode scanner
  • • Traditional QC with target values assigned to QC materials
  • • Numeric or pass/fail QC
  • • QC prompting or QC lock out
  • • Abnormal and critical ranges flagged by color highlighting
  • • Canned or free text user comments
  • • Reject results at meter (optional) for repeat testing
  • • Accept patient ID or accession number
  • • Use of operator password (lockout)
  • • Entry of offline tests
  • • Entry of ICD-9 diagnosis codes
  • • Order physician I.D.
  • • On-screen training mode
  • • Correlation mode
  • • Slope and intercept adjustment
  • • Web-based meter configuration by location
  • • Custom meter configuration by medical unit
  • • Connect to hospital ADT
  • • Connect to all LIS/EMR
  • • POCT1-A2 data output

 

 

Certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards Patented Technology. Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078
Specifications subject to change without notice.




Tests:

Tests Measured: Glucose and Hematocrit
Test Reported: Glucose
Test Time: 6 Seconds
Test Strip Volume: 1.2 µL
Test Methodology: Electrochemistry

Sample Types & Operating Modes:

Whole Blood: Arterial, Venous, Capillary, Neonatal

Glucose Measurement Range:

10-600 mg/dL (0.6-33.3 mmol/L)

Interferences Eliminated Include:

Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen

Operating Ranges:

Temperature: 15°C- 40°C (59°F-104°F)
Altitude: Up to 15,000 feet
Humidity: 10% to 90% relative humidity

Reagents and Strips:

Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial
QC: Three levels (Low, Normal, High); sold separately
Linearity: Five levels available

Test Strip Stability:

24 months from date of manufacturing in USA
180-day open-vial stability

QC Stability:

24 months from date of manufacturing
90-day open-vial stability

Certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards Patented Technology.
Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 Specifications subject to change without notice.