Nova Biomedical- Hospital Based Blood Gas and Critical Care Analyzers

Point-of-Care Whole Blood Creatinine and eGFR Testing


Nova Biomedical- Hospital Based Blood Gas and Critical Care Analyzers

Point-of-Care Whole Blood Creatinine and eGFR Testing

StatSensor® Point-of-Care Creatinine and eGFR Analyzers

Features

StatSensor Creatinine is a handheld analyzer and miniaturized, disposable biosensor for whole blood creatinine testing. StatSensor Creatinine incorporates a patented Multi-Well™ technology adapted from Nova’s hospital glucose monitoring system. StatSensor Creatinine advanced technology enables simple, rapid, and accurate assessment of renal function by finger stick capillary blood sampling at the point of care.

Simple Test Procedure

Place biosensor in meter

Stick finger to create blood drop

Apply blood drop to biosensor

Read creatinine results


Virtually Painless, Finger-Stick Capillary Blood Sample, 1.2 μL

Creatinine and eGFR Results in 30 Seconds

Cleared for Use by Point-of-Care Personnel

Benefits

Radiology and Cardiac Catherization

Minimize Risk of Contrast Induced Nephropathy (CIN) – StatSensor Creatinine provides rapid, real time renal assessment prior to contrast imaging.

Improve Productivity and Workflow – StatSensor Creatinine point-of-care testing can prevent costly procedure room cancellations and workflow interruptions when patients arrive for imaging appointments without a current creatinine/eGFR workup.

Improve Patient Satisfaction – StatSensor Creatinine testing can prevent patient dissatisfaction when renal function must be determined before an imaging procedure can be performed and has not yet been tested when the patient arrivrs for the procedure.

Oncology

Reduce Medication Risks – Renal impairment is frequent in cancer patients, who are at high risk of chemotherapy-induced renal toxicity. StatSensor Creatinine provides important kidney function information for chemotherapy drug selection and dosing.

Improve Patient Satisfaction – Many cancer outpatients need to have their kidney function assessed before receiving their chemotherapy treatments. Obtaining a venous blood sample and sending it to a laboratory for creatinine/eGFR testing could delay chemotherapy for several hours. A chemotherapy treatment that might take a couple of hours could turn into a full day and cause patient dissatisfaction. With StatSensor Creatinine, a capillary blood sample can be obtained and renal function can be quickly determined.

ED: Improve Patient Triage, Expedite Patient Care

Various triage patient care protocols in the emergency department may require rapid assessment of renal function in order to triage the patient. In addition, many ED therapies require timely administration of drugs and adjustment of drug dosage based on renal function. StatSensor Creatinine accurately assesses renal function with a simple, 30- second test that can be easily performed in the ED.

Certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards FDA Labeling: For in-vitro diagnostic use.
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.



Weight:
0.8 lb (220 g)
Size: 6.0 in x 3.25 in x 1.8 in
(153 mm x 82.5 mm x 46 mm)

Tests:

Tests Measured: Creatinine and Hematocrit
Test Reported: Creatinine and eGFR
Test Time: 30 seconds
Test Strip Volume: 1.2 µL
Test Methodology: Electrochemistry

Selectable eGFR Calculation Equations:

MDRD, IDMS traceable MDRD, Schwartz, Counahan-Barratt and Cockroft-Gault

Sample Types & Operating Modes:

Whole Blood: Arterial, Venous, Capillary

Measurement Range:

Creatinine 0.3-12.0 mg/dl (27-1056 µmol/L)

Operating Ranges:

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

Data Storage:

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


Connectivity:

Data Output Port: Etherent (10 Mbit)
Meter Data Output: RJ-45 Ethernet Port
Protocol: TCP/IP Ethernet 100 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.

Reagents and Strips:

Strips: 25 strips per vial ; sold separately
QC: Three levels (Low, Normal, High)
Linearity: Five levels available

Test Strip & QC Stability:

12 months (4-8°c)
3 months open-vial stability

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 ICD-9 diagnosis codes
  • • Order physicians I.D.
  • • Slope and intercept adjustment
    • Custom, web-based meter configuration by location
    • Connect to hospital ADT
    • Connect to all LIS/EMR
    • POCT1-A2 data output
    • Optional Carrying Case


Not available in the United States or Canada


Weight:
0.2 lb (75 g)
Size: 3.6 in x 2.3 in x 0.9 in (91 mm x 58 mm x 23 mm)

Data Storage:

Patient & QC Tests: 400 tests total (FIFO)

Connectivity:

Data Transfer: Strip Port Connection to USB
Data Program: Nova Microsoft-Excel based data transfer software

Battery Information:

Type: 3V Li Button Battery
Features: Replaceable
Life: Minimum 600 tests

Additional Features:

  • • LCD black/white display
    • Large numeric display (30 mm)
    • Traditional QC with target values assigned to QC materials
    • Units of measure based on meter ordered (mg/dl or mmol/L models)
    • Automatic shut-off when not in use
    • Automatic sample detection and analysis start
    • Automatic sample counter with date/time stamp for data tracking

 

Certifications & Compliance: ISO 13485:2003 Quality System Registration, IVDD, Meets IEC 61010, UL, CSA Standards FDA Labeling: For in-vitro diagnostic use.
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.