Version 2020-02 Update text for CLIA Waiver and modified Intended Use statement implementation of supplements for SW Version 2020-08 Update, new SW version 08424705001 (03) 2020-08 USA Accu-Chek Inform II Operator's Manual Version Accu-Chek Inform II System. Version 2017-04 SW and low power icons implemented update to SW new Base Unit in System overview new section What is new new Appendix E for legacy Base Unit misc. Version 2015-03 Correct two typographical errors in chapter 1, Introduction, Overview of the Accu-Chek Inform II.Ģ Base Unit Hub section. Version 2014-02 Transition to new meter hardware 2D barcode scanner, modifications to wireless LAN option (separate insertable RF card replaced by integrated WLAN component) new battery pack. Version 2020-08 Upgrade to FW Revise critically ill statement. Manual version Revision date Changes Version 2012-10 New document Version 2013-02 Upgrade to FW Revise critically ill statement Version 2013-03 Update cleaning and disinfecting chapter Version 2017-04 Add Rx only to Version Operator's Manual. Manual versions 4, 5, 6 and are for Accu-Chek Inform II meters with serial number versions greater than or equal to UU14000000. Operator's Manual Revision History Manual versions 1, 2, 3 and are for Accu-Chek Inform II meters with serial number versions UU13000000 to less than UU14000000. Manual version Revision date Changes Version 1.0 2012-10 New documentġ Accu-Chek Inform II. Manual versions 4, 5, 6 and 7.x are for Accu- Chek Inform II meters with serial number versions greater than or equal to UU14000000. Manual versions 1, 2, 3 and 3.x are for Accu- Chek Inform II meters with serial number versions UU13000000 to less than UU14000000. Version 2015-03 Correct two typographical errors in chapter 1, Introduction, Overview of the Accu-Chek Inform II. Consensus guidelines for the large-scale performance evaluations of POC devices are required.īlood glucose diabetes performance evaluation point-of-care testing.Example: stock market Search Accu-Chek Inform II - Roche DiagnosticsĪccu-Chek Inform II. The Accu-Chek Inform II POC blood glucose meters performed well in terms of precision, linearity, and correlation evaluations. The total correlation coefficient for the 24 devices was 0.998. The correlation coefficient for individual POC devices ranged from 0.9967-0.9985. The test results of all 49 devices were linear within analytical measurement range from 1.55-31.02 mmol/L. The pooled within-site imprecision CV and reproducibility CV of the 12 devices were 2.7% and 2.7% for Level 1, and 1.9%, and 1.9% for Level 2, respectively. The pooled repeatability coefficient of variation (CV) of the 238 devices was 2.0% for Level 1 and 1.6% for Level 2. Mean concentration of control solutions was 2.39 mmol/L for Level 1 and 16.52 mmol/L for Level 2. The glucose results of 24 POC devices and central laboratory were compared using patient samples. The repeatability of 238 POC devices, the within-site imprecision of 12 devices, and the linearity of 49 devices were evaluated using glucose control solutions. The aim of this study was to report the experience of large-scale performance evaluation of 238 Accu-Chek Inform II point-of-care (POC) glucose meters in a single medical setting.
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