BLOOD GLUCOSE MONITORING SYSTEM Operator’s Manual

1 accu - chek inform IIBLOOD GLUCOSE MONITORING SYSTEMO perator s Manualfor meters with a serial number greater than or equal to UU1400000008424705001 (01) 2017-04 USA accu - chek inform II Operator s Manual Version 6 Revision HistoryManual versions 1, 2, 3 and are for accu - chek inform II meters with serial number versions UU13000000 to less than UU14000000. Manual versions 4, 5 and 6 are for accu - chek inform II meters with serial number versions greater than or equal to UU14000000. Manual versionRevision dateChangesVersion documentVersion to FW ; Revise critically ill statementVersion cleaning and disinfecting chapterVersion Rx only to Version Operator s to new meter hardware; 2D barcode scanner, modifications to wireless LAN option (separate insertable RF card replaced by integrated WLAN component); new battery pack.

2 Update to SW ; misc. editorial two typographical errors in chapter 1, Introduction, Overview of the accu - chek inform II Base Unit Hub and low power icons implemented; update to SW ; new Base Unit in SYSTEM overview ; new section What is ; new Appendix E for legacy Base Unit; misc. editorial (01) 2017-04 USAO perator s ManualVersion inform II System08424705001 (01) 2017-04 USA accu - chek inform II Operator s Manual Version 6 2012-2017, Roche Diagnostics. All rights contents of this document, including all graphics, are the property of Roche Diagnostics.

3 No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics. Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this Manual is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product you have questions or comments about this Manual please contact accu - chek Customer , accu - chek inform , accu - chek PERFORMA and COBAS are trademarks of other trademarks are the property of their respective Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi (01)

4 2017-04 USA accu - chek inform II Operator s Manual Version 6On the packaging, on the identification plate of the meter, the battery pack, the base unit, or the code key reader you may encounter the following symbols, shown here with their meaning:On meters with WLAN capability:For other WLAN certifications, see label on bottom of battery , consult accompanying documents. Refer to safety-related notes in the instructions for use accompanying this limitation (Store at) ManufacturerDate of manufactureCatalog numberIn vitro diagnostic medical deviceGlobal Trade Item NumberSerial NumberThe SYSTEM fulfills the Canadian and safety requirements (UL LISTED, in accordance with UL 61010-1 and No.)

5 61010-1).Power supply connection (Base Unit Light)Power supply connection (Base Unit)Rx onlyCaution: Federal law restricts this device to sale by or on the order of a physicianThis device complies with Part 15 of the FCC Rules and with RSS-210 of Industry compliance mark indicates that the product complies with the applicable standard and establishes a traceable link between the equipment and the manufacturer, importer or their agent responsible for compliance and for placing it on the Australian and New Zealand ,25A08424705001 (01) 2017-04 USA accu - chek inform II Operator s Manual Version 6 What is new in publication version section provides an overview of all major changes from Operator s Manual version 5 to version 6.

6 Deletions or minor corrections are not of new features SW and amendments from the supplement (English master document 0 7466161001 (01) 2015-03 EN and all derived transla-tions) have been implemented. New icon (bottle with flashing blue drop) used to prompt sample application for control, proficiency, and linearity tests. For example, see page 78, Applying the control solution . Configurable delay between activation of the scan-ner and reading a barcode (PreAimer Delay). See section Barcode Configuration on page 190. More barcode types supported.

7 See section Barcode Configuration on page 190. Additional information regarding lithium-ion (Li-ion) batteries (Avoidance of electrical shock, fire, and explosions; Possible hazards posed by the battery pack). See section Information regarding shipping. See page power iconsIf the battery pack is running low or not charging prop-erly, the meter will display a series of low power icons. See section Low power icons on page layout safety messagesThe presentation of safety messages in this Manual has been updated throughout. See section Important safety instructions and additional information.

8 Test principleDescription of the test principle used by the meter. See page (01) 2017-04 USA accu - chek inform II Operator s Manual Version 6SW Based on customer feedback, new features have been added and existing ones improved. In case of an automatic power-off, results will be automatically flagged with a standard comment. See page 22. Shut down meter. See page 23. When wireless connectivity is enabled, signal strength bars show the quality of the connection. See page 43. The date of birth (DOB) can now be displayed on patient GLUCOSE test screens. See page 58.

9 Patient ID validation. See page 186. Configurable QC lockout. See page 56. There are separate patient and QC result comment settings. See page 80. Delete Patient Information function has been moved to a new Service Menu. See page 159. OTS workflow: the assessment buttons on the dis-play are bigger and easier to use. See page 227. Workflow for replacing the battery pack has been modified. See page 122. Support of isolation room workflows. Scan the test strip vial before scanning the patient ID. See Supplement E Supplement for Enhanced Work-flows . BLOOD sample type selection.

10 Screen allows you to select and document BLOOD sample type used for a patient test. See Supplement E Supplement for Enhanced Workflows . accu - chek inform II Base Unit The accu - chek inform II Base Unit with new hard-ware and software (REF 07671717190) has replaced the legacy version (REF 05060290001) in this Manual . An overview of the legacy accu - chek inform II Base Unit and technical information have been moved to Appendix (01) 2017-04 USA accu - chek inform II Operator s Manual Version 6 This page intentionally left (01) 2017-04 USA accu - chek inform II Operator s Manual Version 6 What is new in publication version 6SW 6 Low power icons.