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Arkray, Assure Platinum (Bedside Glucose 2013)

Arkray, Assure Platinum (Bedside Glucose 2013)

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Contact Information

Arkray
5198 W. 76th Street
Edina, MN 55439
800-818-8877






Name of instrument/First year sold Assure Platinum/2010
Professional or home use professional
Total units sold in U.S./Total units sold outside U.S. —
No. of contracts for product signed in 2012 1
Dimensions (H × W × D)/Weight 4.5 × 2.5 × 1.2 in/2.8 oz
Analytical method or technology or enzyme system used glucose oxidase
No. of disposable reagent system units per basic package 50 or 100
Disposable units shelf life/Reagent unit storage requirements 18 months/room temperature
Digital readout character size/Keypad input capability —
How results are displayed true values
Specimen types/Sampling techniques whole blood/drop
Minimum specimen volume required 0.5 µL
Suitable for samples from well neonates/Sick neonates no/no
Time from sample introduction to result availability 7 seconds
Batteries used/No. used/Average life of one set of batteries AAA/2/5,000 tests with 4 tests per day
Average expected life of device/Mean time between failures —
Device warranty/Service options/Loaners provided 5 years/—/yes
User list or user group no
Toll-free No. for customer questions/Hours of operation 800-818-8877/24 hours, 7 days
Training & certification program/No. of training days provided yes/one on site
Average time for lab to complete maintenance daily: <5 minutes
Internal QC recommended or required control solution testing
Between instrument CV (based on PT) at the following glucose levels:
• <50 mg/dL —
• 100–200 mg/dL —
• >400 mg/dL —
• Program name, year/Challenge No./Level of mean glucose challenge sample —
Accuracy/Compared to what reference method or device slope=1.0, y-inter.= -2.33, r=0.99/YSI model 2300
Precision/Compared to what reference method or device for glucose results ≥75mg/dL, 100% within ±20%; 96% within ±15%; 79% within ±10%; and 53% within ± 5%. for glucose results <75 mg/dL, 100% within ± 15 mg/dL; 100% within ± 10 mg/dL; 88% within ± 5 mg/dL
Linear range 20–600 mg/dL
Suggested dynamic or measurement range 20–600 mg/dL
Contraindications yes, see labeling
Known interferences/High-altitude interference yes/per labeling
Restrictions based on hematocrit yes, 30–55%
Electronic and optical function checks automatic
Sample quantity checks —
When auto lock or shutdown occurs —
User defines QC lockout intervals/QC lockout can be circumvented —
Information for which device supports bar-code scanning no bar-code scanner
Method of analyst identification/Identification required —
Internal memory size/Maximum No. of patient results stored 500/500 tests
Meter connections for information transfer —
How meters are connected to external system to upload results —
Information contained in transmission to external system —
Hardware/Software for data management system —
No. of different management reports system can produce —
Contents downloaded from DMS to meter —
LISs/HISs to which system is connected (live installs) using:
• Screen animation/Screen scraping —
• Standard HL7 interface —
• Proprietary protocol interface —
Use 3rd-party interfacing tool or engine for LIS or HIS interfaces —
LOINC can be used to identify tests when communicating with LIS —
Distinguishing features (supplied by company) auto coding, no need to manually code the meter; qcProGuard, a 24-hour control solution reminder; strip-release button, no need to touch used test strips
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.