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Medica Corp., EasyStat

Medica Corp., EasyStat

In vitro blood gas analyzers, May 2017

Contact Information

Medica Corp.
sales@medicacorp.com
5 Oak Park Drive
Bedford, MA 01730
781-275-4892


Name of device/First year sold/Number of analyzers sold in 2016 EasyStat/2002/—
Number of devices sold in U.S./Outside U.S./List price —/>1,000/$12,500
Dimensions (H x W x D)/Weight 12.5 × 14.5 × 7 inches/16 pounds
Analytes measured on device pH, pCO2, pO2, Hct, Na, K, Cl, iCa
Parameters calculated on device Hb, 02SAT, BE, TCO2, HCO3
Barometric pressure recorded, measured
Analytical method(s) or technologies employed pH, iCa, pCO2, pO2, Na, Cl, K: ISE-potentiometry; Hct: conductivity; Hb: calculated from Hct
Device is part of a series of related models yes (expanded parameter menu; related to EasyBloodGas)
Device warranty/Loaner devices provided 1 year/yes
Average life expectancy of device 7–10 years
Open or closed system/External gas tanks required closed/no
Categorized for point-of-care testing or laboratory laboratory
Point of care:
Disposable prepackaged system used for analysis reagent/electrode
No. of disposable reagent system units in standard package 1
No. of samples analyzed per one disposable reagent, electrode system based on testing volume per day
Reagent unit storage requirements room temperature
Shelf life of disposable units reagents: 12 months; electrodes: 12 months
Laboratory:
No. of different disposable reagents required to maintain device 1
Max. No. of analyte reagents that can reside in device at once 1
Shelf life of components reagents: 12 months; electrodes: 12 months
Cost per test/Reagent cost per test <$0.13 at 20 samples per day/$0.06 at 20 samples per day
Calibrations required 1 and 2 point (manual and automatic)
Calibration frequency 1 point (with every sample analysis); 2 point (can be set for 2-, 4-, or 8-hour increments)
Internal QC program recommended 3 controls, 1 level per 8 hours, CLIA recommendations, Medica controls recommended
QC features/Capabilities of QC features L-J plots/statistical calculations, monthly cumulative reports
Remote control of device from laboratory no
System can use LOINC to transmit results to LIS no
Specimen types suitable for device plasma, serum, whole blood, capillary, mixed venous, arterial, venous
Acceptable anticoagulants/Sampling technique heparin/aspiration
Sample size for complete panel of analyte results 100 µL; 95 µL capillary
Sample size differs with number of analytes selected no
Time from sample introduction to result availability <120 seconds (includes 1-point calibration)
Max. No. of patient samples per hour/Max. No. measured results per hour 30/210
Optimal throughput when analyzer calibrated, awaiting specimens 30 tests per hour
Calibration can be interrupted to perform stat sample yes
Known interferences incorrect anticoagulant
Sampler has self-wiping probe yes
Time required for maintenance by lab personnel daily: 0.5 minutes; weekly: 3.5 minutes; monthly: 15 minutes
Service center performs diagnostics through modem no
Method of analyst ID in system manual or barcode wand for ID entry (optional)
Instrument response for:
• hardware failure/software failure operator warning, error messages/error messages, user ID: sampling lockout
• QC failure flagged results
• calibration failure error messages, second attempt for 2-point calibration automatically
For what barcode scanning is provided operator identifier, patient identifier, QC control, reagent pack automatically read when reagent module installed
Built-in printer/Data port yes/RS-232
Information listed on hard copy report patient information, measured and calculated parameters, date, operator ID
Analyzer connections data-management system, which connects to LIS/HIS; directly to LIS/HIS
Interface standards supported Medica protocol
How analyzer connects to external system to upload patient and QC results direct serial
Information included in transmission from analyzer to external system operator ID, patient ID, results
Hardware and software for data-management system internal
No. of different management reports system produces QC, L-J charts, patient reports
Contents downloaded from data-management system to analyzer
System connected (live installations) to which LISs, HISs
Use a third-party interfacing tool, engine for LIS, HIS interfaces no
Distinguishing features (supplied by company) modular components; simple operation and maintenance; low operation cost; disposable, maintenance-free sensors; no gas tanks; easy inside and out
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.