Attachment B - Chemistry Analyzer Essential Characteristics.pdf
PDF 151 KB Posted
- Solicitation number
- HT940625ChemicalAnalyzer
- Issued by
-
Defense Health Agency
About this file
Attachment B details the essential characteristics for a Chemistry Analyzer intended for the 78th Medical Group Laboratory at Robins Air Force Base. The analyzer must have specific technical capabilities including a maximum throughput of 800 tests/hour, batch/random access operational type, color touchscreen interface, and onboard data storage with 25,000 sample result capacity. Key technical specifications include sample handling for serum/plasma/urine, automatic dilution and reflex testing capabilities, sample probe carryover of 0.1 parts per million, and compatibility with multiple barcode types.
The system requires specific environmental and operational parameters, including electrical requirements of 15 amp, 100-240V AC, operating temperature between 15-30°C, and no external water/drain requirements. Reagent characteristics mandate minimum 55 onboard assay capacity, 35-day reagent stability, and ready-to-use reagents without preparation. The analyzer must also have bidirectional host interface capabilities using ASTM and HL7 protocols, be compatible with Military Health System GENESIS electronic health record system, and have an approved Authority to Operate (ATO) certificate from the Defense Health Agency. The intended sole source contractor is Ortho Clinical Diagnostics, Inc., with a contract structure including a base period and four option years.
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| File | Type | Posted |
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| Attachment A - Test Menu Requirements.pdf |
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Text version
Chemistry Analyzer Essential Characteristics
ANALYZER SYSTEM CHARACTERISTICS
MEASUREMENT PRINCIPLE Colorimetric-Rate, Potentiometric (direct ISE), Photometric MAXIMUM THROUGHTPUT Up to 800 tests/hour
OPERATIONAL TYPE Batch, random access, continuous random access OPERATOR INTERFACE Color touchscreen monitor, keyboard, numeric keypad, scanner, graphical interface, printer
ONBOARD SAMPLE & REAGENT
MANAGEMENT
Onboard traceability and documentation of result quality
ONBOARD MAINTENANCE
RECORDS
Required
ONBOARD HELP FUNCTION Required DATA STORAGE Read/Write Hard drive
USB flash drive capabilities Archive and retrieve capabilities Minimum: 10,000 sample program capabilities Minimum: 25,000 sample results storage
STARTUP No manual primes, purges, washes or tubing maintenance No daily calibrations or calibration checks
DIMENSIONS Maximum Height: 53 inches Maximum Width: 63 inches Maximum Depth: 36 inches
WEIGHT Maximum: 1200 lbs
COMMUNICATIONS
HOST INTERFACE Bidirectional interface (ASTM and HL7 protocols) Broadcast download and Host Query Result upload variation
PORTS RS 232 serial ports USB ports Ethernet ports
SAMPLE CHARACTERISTICS
SAMPLE TYPES Serum, Plasma, Urine SAMPLE TUBES 5mL, 7mL, 10mL, Micro-containers
SAMPLE CUP 0.5mL, 2.0mL, Dead Volume: 35µL SAMPLE VOLUME 2.7 - 75µL
SAMPLE CAPACITY Minimum: 80 samples SAMPLE BARCODE TYPES Code 128, ISBT 128, Code 39, Codabar, Interleaved 2 of 5
DILUTION CAPABILITIES Automatic, Operator Requested, Off-board dilution calculation
AUTOMATIC REFLEX TESTING Required AUTOMATIC RERUN CAPABILITY Required
SAMPLE PROBE CARRYOVER ≤0.1 parts per million LIQUID LEVEL DETECTION Required
SAMPLE CLOT & BUBBLE
DETECTION
Required
SAMPLE INTERFERENCE
MEASUREMENT
Detection & flagging of results affected by Hemolysis, Icterus, Lipemia (Turbidity)
SAMPLE LOADING Priority STAT processing capabilities Continuous load and unload capabilities
Chemistry Analyzer Essential Characteristics
REAGENT AND CONSUMABLES CHARACTERISTICS
CONSUMABLES Replenishment without interrupting system operation
ONBOARD ASSAY CAPACITY Minimum: 55 Replenishment without interrupting incubation
REAGENT TYPE Ready-to-use, no preparation, no mixing or reconstitution required
ONBOARD REAGENT STABILITY Minimum: 35 days
REAGENT LOT TRACKING &
INVENTORY
Required
CALIBRATION FREQUENCY 6 months or lot change Multiple lots per assay with automatic lot switching Bar-coded calibrators Random-access calibration
ENVIRONMENT CHARACTERISTICS
ELECTRICAL REQUIREMENTS Line Voltage: 15 amp, 100-240V AC
Line Frequency: 47-63 Hz UPS BACKUP POWER SUPPLY Required
OPERATING TEMPERATURE 15°-30°C/59°-86°F
HUMIDITY REQUIREMENTS 15%-75% RH
WATER REQUIREMENTS No water or drain required; self-contained onboard waste management
HEAT OUTPUT Maximum: 2500 BTU/hr (733 W) NOISE Maximum Idle: 60dB
Maximum Operating: 60 dB
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