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Name of instrument/First year sold | Accu-Chek Inform II System/2012 |
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 | 1.85 × 3.62 × 7.48 in/12.35 oz (350 g) |
Analytical method or technology or enzyme system used | electrochemical (AC/DC), mutant variant quinoprotein glucose dehydrogenase |
No. of disposable reagent system units per basic package | 50 strips per vial |
Disposable units shelf life/Reagent unit storage requirements | 18 months/39°–86°F (4°–30°C) |
Digital readout character size/Keypad input capability | test results are 48-point font/menu selection, numeric, alphabetic |
How results are displayed | plasma equivalent values |
Specimen types/Sampling techniques | fresh capillary, venous, arterial, neonate whole blood/drop |
Minimum specimen volume required | 0.6 µL |
Suitable for samples from well neonates/Sick neonates | yes/yes |
Time from sample introduction to result availability | 5 seconds |
Batteries used/No. used/Average life of one set of batteries | 3.7v Li-polymer (rechargeable)/1/5 years |
Average expected life of device/Mean time between failures | 5 years/— |
Device warranty/Service options/Loaners provided | 1 year or for term of contract/replacement/no |
User list or user group | yes |
Toll-free No. for customer questions/Hours of operation | 800-440-3638/24 hours, 7 days, all year |
Training and certification program/No. of training days provided | yes/defined during implementation planning |
Average time for lab to complete maintenance | none beyond cleaning and disinfection |
Internal QC recommended or required | follow facility policy for control testing intervals |
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 | capillary: r=0.993, venous: r=0.995, arterial: r=0.990, neonatal: r=0.976/hexokinase method traceable to NIST |
Precision/Compared with what reference method or device | controls: low SD=1.2 mg/dL, mid SD=2.2, high SD=4.6, low CV=2.6%, mid CV=1.9%, high CV=1.5%; blood: 1 SD=1.2 mg/dL, 3 SD=4.2 mg/dL, 5 SD=9.5 mg/dL, 1 CV=3.3%, 3 CV=3.4%, 5 CV=3.0%/hexokinase method traceable to NIST |
Linear range | 10–600 mg/dL |
Suggested dynamic or measurement range | 10–600 mg/dL |
Contraindications | yes, per labeling |
Known interferences/High-altitude interference | per labeling/none, up to 10,000 feet |
Restrictions based on hematocrit | yes, 10–65% |
Electronic and optical function checks | 150 integrity checks, including variation in hematocrit, temperature, and humidity |
Sample quantity checks | sampling checked electronically for complete sample dosing |
When auto lock or shutdown occurs | user ID failure, QC failure, download interval lockout |
User defines QC lockout intervals/QC lockout can be circumvented | yes/no |
Information for which device supports barcode scanning | operator ID, patient ID, reagent lot, QC lot |
Method of analyst ID/ID required | alphanumeric or barcode scan/required |
Internal memory size/Maximum No. of patient results stored | 1,000 results, 5,000 operator IDs, 4,000 patient IDs, 300 predefined comments/— |
Meter connections for information transfer | data-management system, which connects to LIS-HIS |
How meters are connected to external system to upload results | direct serial, hospital network, real-time wireless (RF) |
Information contained in transmission to external system | device unique identifier, operator ID, patient ID, result, QC identifier, strip lot numbers, proficiency and linearity samples, comments |
Hardware/software for data-management system | Cobas IT 1000 application for connection to third-party DMS, including Telcor QML, Alere RALS |
No. of different management reports system can produce | varies by data manager (customer defined) |
Contents downloaded from DMS to meter | strip lot numbers, valid control values, valid operator IDs, patient IDs, meter configuration, linearity lot numbers and values, comments |
LISs/HISs to which system is connected (live installs) using: | |
• Screen animation/Screen scraping | — |
• Standard HL7 interface | yes |
• Proprietary protocol interface | — |
Use 3rd-party interfacing tool or engine for LIS or HIS interfaces | yes, Telcor QML or Alere RALS |
LOINC can be used to identify tests when communicating with LIS | yes |
Distinguishing features (supplied by company) | smooth, durable sealed housing designed for hospital use that withstands cleaning, disinfecting, and penetration of liquid; 150 individual quality checks are conducted prior to measuring the glucose concentration, including test strip, meter, data, and dosing; patented dual-current AC/DC meter technology checks a wide range of variables including compensation for hematocrit; meter-level wireless technology for real-time data transfer without need of docking the meter; code key ensures lot-specific calibration to minimize bias for consistent, accurate results; extensive studies to prove system performance in the presence of potential interferences following CLSI guidelines; award-winning, live 24/7/365 customer care service and support |
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. |