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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. |
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