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 Glucose Measuring System

Only glucose meters accurate enough to be FDA-cleared for use with ALL patients,
including critically ill

ONLY glucose meters cleared by the FDA for use with all patients, in all professional healthcare settings, including critical care
ONLY glucose meters that are CLIA-waived for use with all patients including critically ill


Accuracy proven in study of 1,698 critically ill patients with over 257 medical conditions

• Improved accuracy results in fewer insulin misdoses and better outcomes for critically ill patients

Excellent correlation to
IDMS traceable laboratory methods
• ONLY glucose meter proven to have no known clinical interferences
• Tested over 8,000 medications with no interferences

1. U.S. Food and Drug Administration. (2014, September 24). FDA clears glucose monitoring system for use in hospital critical care units [Press release]. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm
2. U.S. Department of Health and Human Services, Food and Drug Administration. (2014). Blood glucose monitoring test systems for prescription point-of-care use. Draft guidance for industry and food and drug administration staff. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf






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.