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Nova Biomedical, USA
- Statstrip Xpress2 is the world’s ONLY US FDA APPROVED PROFESSIONAL GLUCOSE METER APPROVED FOR USE IN ALL HOSPITAL PATIENTS, INCLUDING THE CRITICALLY ILL
- With its patented multi-layer, multi-well technology, Statstrip is highly superior to all other meters & strips in the market and eliminates all known interferences that affect Glucose measurements.
- Incorporated in 1976 and based in Waltham, MA, USA, Nova Biomedical is a world leader in the development and manufacturing of state-of-the-art, whole blood, point-of-care and critical care analyzers, as well as providing the biotechnology industry with the most advanced instruments for cell culture monitoring. Nova is one of the fastest growing in vitro diagnostic companies in the world.
Products:
Hospital Point-of-Care Connectivity Meters- StatStrip Xpress 2 Glu/Ket
- StatStrip Xpress 2 Lactate, Hb & Hct meter
- Lactate Plus meter for Sports Medicine
- Link to Nova Biomedical website: http://www.excel.com/
Specifications
StatStrip Xpress2 Glucose/Ketone Meter
Designed for applications that do not need data interfacing and connectivity, Xpress2 retains all of the analytical performance features of StatStrip Glucose.
- Weight: 2.77 oz (78 g)
- Size: 3.9 in x 2.4 in x 0.9 in
- (98 mm x 61 mm x 22.9 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: Type: 2x 1.5V AAA Battery
- Features: Replaceable
- Life: Minimum 600 tests
Additional Features:
- LCD color 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 and Compliance: Nova Biomedical is certified to FDA Quality System Regulations and EN ISO 13485:2016 Complies to IVDD Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. 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.
StatStrip Glucose/Ketone Connectivity Meter
- 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)
Glucose and Ketone Testing in One Meter (ADA recommends ketone testing when glucose >250 mg/dL or >14 mmol/L)
- Glucose Results in 6 Seconds, Ketone Results in 10 Seconds
- 1.2 Microliter Sample for Glucose
- 0.8 Microliter Sample for Ketone
- Simple, Color Touchscreen Operation
Data Storage:
- Patient Tests: 1,000 tests QC Tests: 200 tests Users: 8,000 users
Connectivity:
- Meter Data Output: RJ-45 Ethernet Port Protocol: TCP/IP Ethernet 100 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 of results at meter (optional) for repeat testing
- Flag Tight Glycemic Control results
- Accept patient ID or accession number
- Use of operator password (lockout)
- Entry of offline tests
- Entry of ICD-9 diagnosis codes
- Order physician ID
- Onscreen 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
StatStrip Xpress2 Glucose/Ketone Meter
Tests:
- Test Measured: Ketone*, Hematocrit corrected
- Test Reported: Ketone
- Test Time: 10 Seconds
- Test Strip Volume: 0.8 μl
- Ketone Measurement Range: 0.0-8.0 mmol/L
- *ß-hydroxybutyrate
Sample Types & Operating Modes:
- Whole Blood: Arterial, Venous, Capillary
Operating Ranges:
- Temperature: 41°F-104°F (5°C- 40°C)
- Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity
- Hematocrit: 20%-65%
Reagents and Strips:
- Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box)
- QC: Three levels (Low, Normal, High)
- Linearity: Five levels available
StatStrip Glucose Test Strips
Tests:
- Tests Measured: Glucose and Hematocrit
- Test Reported: Glucose
- Test Time: 6 Seconds
- Test Strip Volume: 1.2 µL
- Test Methodology: Electrochemistry
QC Stability:
- 24 months from date of manufacturing 180-day open-vial stability
Test Strip Stability:
- 30 months from date of manufacturing outside USA 180-day open-vial stability
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
Operating Ranges:
- Temperature: 15°C- 40°C (59°F-104°F)
- Altitude: Up to 15,000 feet
- Humidity: 10% to 90% relative humidity
Glucose Measurement Range:
- 10-600 mg/dL (0.6-33.3 mmol/L)
Sample Types & Operating Modes:
- Whole Blood: Arterial, Venous, Capillary, Neonatal
Certifications and Compliance: Nova Biomedical is certified to FDA Quality System Regulations and EN ISO 13485:2016 Complies to IVDD Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014.
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 current as of revision date.