DxC 500i Clinical Analyzer

Analytical method

Analytical principles

Assay types

• Chemistry: Endpoint, rate, fixed point, indirect ISE
• Immunoassay: Competitive assay, Sandwich assay, and Antibody detection assay

Analytical method

• Chemistry: Colorimetry, turbidimetry, latex agglutination, and indirect ISE
• Immunoassay: Paramagnetic coated antibody/antigen

Chemistry menu capacity

Throughput

• 400 photometric tests per hour, up to 800 with ISE
• 100 immunoassay tests per hour (one-step assays)
• ISE maximum test per hour: 600 if ISE only
• HbA1c maximum tests per hour: 65 if HbA1c only

Sample types (assay dependent)

Sample management/capacity

• 168 sample tubes (24 racks of 7 tubes), unique continuous loading feature
• Independent analysis:
  • Chemistry: 22 samples in refrigerated STAT carousel
  • Immunoassay: 60 samples in 6 carousel racks

Barcoded reagents

Sample container sizes

• Sample tubes:
  • 13 x 75 mm, 13 x 100 mm, 16 x 100 mm
  • Sarstedt S-Monovette 4.9 mL, 5.5 mL, 7.5 mL
• Cups/insert cups:
  • 0.5 mL, 2.5 mL, 3.0 mL cups
  • 1.0 mL, 2.0 mL insert cups, pediatric insert
  • Auto aliquot

Sample volume (assay dependent)

• Chemistry: 1.0 –25 μL in 0.1 μL increments (assay dependent)
• Immunoassay: 10–110 μL

Sample barcode symbology

Compartment temperatures

• Chemistry:
  • Chemistry reagent compartment: 39.2°F to 53.6°F (4°C to 12°C)
  • STAT wheel: 39.2°F to 53.6°F (4°C to 12°C)
  • Cuvette wheel: 98.6°F ± 0.5°F (37°C ± 0.3°C)
• Immunoassay:
  • Reagent compartment: 33°F to 41°F (1°C to 5°C)
  • Maintains air and reagent temperature at 37.4°F to 50°F (3°C to 10°C)
  • Incubator and wash/read wheel: 97.5°F ± 0.5°F (36.4°C ± 0.3°C)

Reagent storage capacity

• Chemistry: 76 positions in a refrigerated reagent carousel that holds 15 mL, 30 mL, and 60 mL bottle sizes
• Immunoassay: 24 positions in refrigerated reagent carousel

Reaction cuvette

• Chemistry: Permanent glass cuvettes
• Immunoassay: Disposable reaction vessels

Sample quality analysis

• Lipemia, hemolysis, and icterus indices
• Clot detection and probe crash protection

Calibration (assay dependent)

• Chemistry: calibration curve stability up to 90 days
• Immunoassay: calibration stability up to 63 days
• Calibration curves and parameters displayed on screen
• Calibrator setpoint entry through barcode scan

Quality control

• Shewhart day-to-day management (Levey-Jennings method)
• Multi-rule control (Westgard method)

Dimensions and weight

• Analyzer with monitor:
  • Weight: Dry, 1,430 pounds (<650 kg)
  • Length: 100 in (254 cm)
  • Height: 48.8 in (124 cm)
  • Height with monitor: 63.0 in (160 cm)
  • Depth: 30.3 in (77 cm)

Clearance Requirements

• Clearance around the analyzer for ventilation:
  • Rear: minimum of 24 in (64 cm)
  • Left: minimum of 20 in (50 cm)
  • Right: minimum of 20 in (50 cm)
  • Front: minimum of 25 in (63.5 cm)>
  • Top (from the top of the chemistry analyzer): Minimum of 49 in (124 cm)

Waste requirements

• Chemistry module drain location:
  • Maximum distance: 33 ft (10 m) from the system
  • Maximum height: 5 ft (1.5 m) from the floor
• Chemistry module drain volume:
  • Concentrated waste: 5.5 L/hour (normal), 7.5 L/hour HbA1c
  • Diluted waste: 12 L/hour
• Immunoassay module drain location:
  • Maximum distance 9.8 ft (3 m) from the system
  • Maximum height 3 ft (0.9 m) from the floor
• Immunoassay module drain volume:
  • 1 L/hour
• Immunoassay module solid waste: (RVs):
  • RVs collected in RV waste bag (300 RV capacity)

Water supply requirements

• Maximum water consumption: 20 L/hour
• Water type: Deionized CAP type II or better, bacteria free
• Continuous flow supply
• Resistivity: > 0.5 MΩ∙cm filtered with a 0.5 μm filter

Power and environmental requirements

Computer

• Storage: 960GB SSD
• Operating system: Windows 10
• External communication types: RS232 serial interface
• Ethernet: LAN using TCP/IP

Monitor

• Touchscreen display: 21.5 in (54.6 cm) diagonal TFT LCD with projected capacitive touch
• Pixels: 1920 x 1080 RGB

Operating environment

• Ambient temperature: 64°F to 82°F (18°C to 28°C)
• Humidity: 20% to 80% RH (without condensation)
• Altitude: Maximum 2,000 m (6,561 ft) above sea level
• Noise level: <75 dBA

Communication modes