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STATSENSOR (TM) CREATININE MONITORING SYSTEM

StatSensor Specifications

Test Measured:

Creatinine
Tests Reported:

Creatinine

eGFR
Test Time:

30 seconds
Test Strip Volume:

1.2 μL
Test Methodology:

Electrochemistry
Weight:

360 g (0.8 lbs)
Size:

153 mm x 82.5 mm x 46 mm
(6.0 in x 3.25 in x 1.8 in )

Sample Types and Operating Modes:

Whole Blood:

Arterial, Venous, Capillary

Measurement Range:

Creatinine:

27-1050 μmol/L (0.3-12.0 mg/dL)

Operating Ranges:

Temperature:

15°C- 40°C (59°F-104°F)
Altitude:

Up to 4,454 meters (15,000 feet)
Humidity:

10% to 90% relative humidity

Reagents and Strips:

Strips:

25 strips per vial/box of 50
QC:

Three levels (Low, Normal, High);
sold separately
Linearity:

Five levels available

Test Strip Stability:

Refrigerated Storage:
12 months 2°C-8°C (36°F-46°F)
Room Temperature Storage:
3 months
eGFR and CrCl Equations:

MDRD for Glomerular Filtration Rate (eGFR) and Cockcroft-Gault for Creatinine Clearance (CrCl)
Certifications and Compliance:

ISO 9001 Quality System Registration, CSA, TÜV, IVDD, CE Self Declared Complies to EN 61010, EN 50081,82
FDA Labeling:

For in-vitro diagnostic use
Data Storage:

Patient Tests:


1,000 tests
QC Tests:

200 tests
Users:

4,000 users
Connectivity:

Data Output Port:


Ethernet (10 Mbit)
Meter Data Output:

RJ-45 Ethernet Port
Protocol:

TCP/IP Ethernet 10 Mbit
Standard:

POCT1-A Compliant
Setup Program:

NovaNet™ Web-Based
Instrument Manager Software
Battery Information:

Type:


3.7V Li Polymer Rechargeable Battery
Features:

Rechargeable/Replaceable
Life:

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 touch screen
  • 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
  • Rejecting of results at meter (optional) for repeat testing
  • Accepting patient ID or accession number
  • Use of operator password (lockout)
  • Entry of ICD-9 Diagnosis codes
  • Ordering physicians I.D.
  • 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-A data output
  • Optional Carrying Case

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