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Arkray, Assure Prism multi (BedsideGlucose_2018)

Arkray, Assure Prism multi (BedsideGlucose_2018)

Bedside glucose testing systems, April 2018

Contact Information

Arkray
Edina, MN
800-818-8877






Name of instrument/First year sold Assure Prism multi/2015
Professional or home use professional
Total units sold in U.S./Total units sold outside U.S.
No. of contracts for product signed in 2017
Dimensions (H × W × D)/Weight 3.66 × 2.2 × 0.83 in/2.1 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 expiration date printed on each bottle/34°–86°F
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 5 seconds
Batteries used/No. used/Average life of one set of batteries 3v lithium (disposable, type CR2032)/2/1,000 tests
Average expected life of device/Mean time between failures 3 years/—
Device warranty/Service options/Loaners provided 3 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 and certification program/No. of training days provided yes/one on site
Average time for lab to complete maintenance
Internal QC recommended or required control solution testing recommended for each new meter and bottle of test strips
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 with what reference method or device slope=1.0, y-inter.= -7.39 mg/dL, r=0.99/YSI model 2300 glucose analyzer
Precision/Compared with what reference method or device results for glucose concentration ≥75 mg/dL: 100% within ±20%; 98% within ±15%; 80% within ±10%; 42% within ±5%; results for glucose concentration <75 mg/dL: 100% within ±15%; 100% within ±10%; 100% within ±5%/ YSI model 2300 glucose analyzer
Linear range 20–600 mg/dL
Suggested dynamic or measurement range 20–600 mg/dL
Contraindications per labeling
Known interferences/High-altitude interference yes, see labeling/none, up to 10,000 feet
Restrictions based on hematocrit yes, 20–60%
Electronic and optical function checks automatic
Sample quantity checks fill-trigger electrode on each test strip designed to start the test when sufficient sample is detected
When auto lock or shutdown occurs user flags control solution tests when conducted
User defines QC lockout intervals/QC lockout can be circumvented no/no
Information for which device supports barcode scanning no barcode scanner
Method of analyst ID/ID 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) optimized readout display: large, thick numbers are intended to improve readability; compact design: small, lightweight design provides better portability; other features: auto coding, LCD backlit display, and test strip ejector
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.