VO9-ACI2PAN9028IVD for monitoring blood glucose. (BGM)

Document Information: Document Author: Ioannidis-Aykan, Suna {DSSD~Mannheim} Business Area / Unit: Global Platforms & Support Confidentiality: Confidential Document Class: Device Master Record Document Type: Device Master Record Document Creator: Ioannidis-Aykan, Suna {DSSD~Mannheim} Document Lifecycle Status: Effective Valid From: 08-Dec-2021 19:43:51 (UTC) Valid To: Document Title: AC_Inform_II_OM_V8.0_08424705001-06_EN-U Document Number: 0000000000001200000539934 Document Version: 02 Template: No Global Group: Product Documentation Global SubGroup: Operators Manual Language: English Site: Mannheim Department: Global Customer Support Document Description: AC_Inform_II_OM_V8.0_08424705001-06_EN-USA Document Material Number: 08424705001 Description of change: ECR 400174253 Added information on open test strip vials. Electronic Signatures: Signed By: andrewm3 (Mark Andrews {DNRDA}) Role: Reviewer Signature Differentiation: Marketing Signed Date: 08-Dec-2021 18:13:23 (UTC) Signed By: mckenza1 (Amy McKenzie {DNPOA}) Role: Reviewer Signature Differentiation: Technical Writer Signed Date: 08-Dec-2021 15:43:07 (UTC) Signed By: ioannids (Suna Ioannidis-Aykan {DSSDPA}) Role: Approver Signature Differentiation: Global Customer Support Signed Date: 08-Dec-2021 19:36:20 (UTC) This copy will not be updated. Verify the status of this version in DiaDoc or contact your ROCHE representative prior to use. Diese Kopie wird nicht aktualisiert. Überprüfen Sie vor Gebrauch den Status dieser Version im DiaDoc oder kontaktieren Sie Ihren ROCHE Ansprechpartner. Esta copia no va a ser actualizada. Verifique el “status” de esta versión en DiaDoc o contacte a su representante de ROCHE antes de utilizarla. Confidentiality: Confidential Title: AC_Inform_II_OM_V8.0_08424705001-06_EN-UDocument Number: 0000000000001200000539934 Print Comment: Print Date: Version: 02Status: EffectiveValid from: 08-Dec-2021 19:43:51 (UTC) Cover Page 1 (1) Accu-Chek ® Inform II BLOOD GLUCOSE MONITORING SYSTEM Operator’s Manual Confidentiality: Confidential Title: AC_Inform_II_OM_V8.0_08424705001-06_EN-UDocument Number: 0000000000001200000539934 Print Comment: Print Date: Version: 02Status: EffectiveValid from: 08-Dec-2021 19:43:51 (UTC) Content Page 1 (276) 208424705001 (06) 2021-11 USA • Accu-Chek Inform II Operator’s Manual Version 8.0 Revision History Manual versions 1, 2, 3 and 3.x are for Accu-Chek Inform II meters with serial number versions UU13000000 to less than UU14000000. 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 versionRevision dateChanges Version 1.02012-10New document Version 2.02013-02Upgrade to FW 03.04; Revise critically ill statement Version 3.02013-03Update cleaning and disinfecting chapter Version 3.12017-04Add “Rx only” to Version 3.0 Operator’s Manual. Version 3.22020-08Upgrade to FW 03.07; Revise critically ill statement. Version 4.02014-02Transition to new meter hardware; 2D barcode scanner, modifications to wireless LAN option (separate insertable RF card replaced by integrated WLAN component); new battery pack. Update to SW 04.00; misc. editorial revisions. Version 5.02015-03Correct two typographical errors in chapter 1, Introduction, Overview of the Accu-Chek Inform II Base Unit Hub section. Version 6.02017-04SW 04.01 and low power icons implemented; update to SW 04.02; new Base Unit in “System overview”; new section “What is new...”; new Appendix E for legacy Base Unit; misc. editorial revisions. Version 7.02020-02Update text for CLIA Waiver and modified Intended Use statement; implementation of supplements for SW 04.03 Version 7.12020-08Update, new SW version 04.04 Version 7.22021-05Updated information on WLAN regulatory registration. Version 7.32021-09Added information on open test strip containers. Version 8.02021-11Update, new SW version 04.06; WLAN 5GHz support; Implementation of supplements for SW 04.04; Implementation of IVDR related requirements (IVDR: in vitro diagnostics regulation); TLS authentication; Updated information in cleaning and disinfecting section. Confidentiality: Confidential Title: AC_Inform_II_OM_V8.0_08424705001-06_EN-UDocument Number: 0000000000001200000539934 Print Comment: Print Date: Version: 02Status: EffectiveValid from: 08-Dec-2021 19:43:51 (UTC) Content Page 2 (276) 08424705001 (06) 2021-11 USA Operator’s Manual Version 8.0 AACCU-CCU-CHEKHEK ® Inform II System Confidentiality: Confidential Title: AC_Inform_II_OM_V8.0_08424705001-06_EN-UDocument Number: 0000000000001200000539934 Print Comment: Print Date: Version: 02Status: EffectiveValid from: 08-Dec-2021 19:43:51 (UTC) Content Page 3 (276) 408424705001 (06) 2021-11 USA • Accu-Chek Inform II Operator’s Manual Version 8.0 © 2012-2021, Roche Diagnostics. All rights reserved. The contents of this document, including all graphics, are the property of Roche Diagnostics. 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 development. Electronic user documentation can be downloaded using the eLabDoc e-service on Dialog: www.dialog.roche.com/ For more information, contact your local affiliate or Roche Service representative. ACCU-CHEK, ACCU-CHEK INFORM and COBAS are trademarks of Roche. All other trademarks are the property of their respective owners. On 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: The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance. Caution, consult accompanying docume…

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cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 1 of 35 Annex A201 – Calibration Data No. 1-1438-25-01-10_TR1-A201-R01 This test report is electronically signed and valid without handwritten signature. Public keys for verification of the electronic signatures can be requested at the testing laboratory. March 23, 2026 authorized by Alexander Hnatovskiy Coordinator Area Regulatory Services Radio Description Detailed SAR System calibration data cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 2 of 35 Table of content 1 Calibration report “Probe EX3DV4” – SN: 3944 .................................................................................................... 3 2 Calibration report “2450 MHz System check dipole” ......................................................................................... 13 3 Calibration report “5 GHz System check dipole” ................................................................................................ 18 4 Calibration certificate of Data Acquisition Unit (DAE) – SN: 477 ...................................................................... 27 5 Certificate of “SAM Twin Phantom V8.0” ............................................................................................................ 28 6 Certificate of “ELI Phantom V8.0” ........................................................................................................................ 29 7 Application note system performance check ..................................................................................................... 30 7.1 Purpose of system performance check ........................................................................................................ 30 7.2 System performance check procedure ......................................................................................................... 30 7.3 Uncertainty Budget ......................................................................................................................................... 31 7.4 Power set-up for validation ............................................................................................................................ 34 7.5 Laboratory reflection ...................................................................................................................................... 35 7.6 Additional system checks .............................................................................................................................. 35 2012-02012-01-16-16 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 3 of 35 1 Calibration report “Probe EX3DV4” – SN: 3944 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 4 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 5 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 6 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 7 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 8 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 9 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 10 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 11 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 12 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 13 of 35 2 Calibration report “2450 MHz System check dipole” cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 14 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 15 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 16 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 17 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 18 of 35 3 Calibration report “5 GHz System check dipole” cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 19 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 20 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 21 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 22 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 23 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 24 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 25 of 35 cetecom advanced GmbH Document No. 1-1438-25-01-10_TR1-A201-R01 Untertuerkheimer Str. 6-10, 66117 Saarbruecken Page 26 of 35 Antenna Parameters with Head TSL at 5200 MHz From cal. data Measured 2025-06-06 Impedance; transformed to feed point 50.4Ω - 9.4jΩ 48.6Ω +0.3jΩ Return Loss -20.6dB -26.8dB Antenna Parameters wit…

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Annex A101 - Photographs No. 1-1438-25-01-10_TR1-A101-R01 March 20, 2026 DescriptionPhotos of EUT and test position This document is electronically signed and valid without handwritten signature. Public keys for verifcation of the electronic signatures can be requested at the testing laboratory. Alexander Hnatovskiy Coordinator Area Regulatory Services Radio authorized by cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-10_TR1-A101-R01 Page 1 of 8 Photo 1 DUT - front view Photo 2 DUT - back view cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-10_TR1-A101-R01 Page 2 of 8 Photo 3 DUT - right view Photo 4 DUT - back view opened cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-10_TR1-A101-R01 Page 3 of 8 Photo 5 Battery Photo 6 Test position front side without any distance cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-10_TR1-A101-R01 Page 4 of 8 Photo 7 Test position back side without any distance Photo 8 Test position left side without any distance cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-10_TR1-A101-R01 Page 5 of 8 Photo 9 Test position right side without any distance Photo 10 Test position top side without any distance cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-10_TR1-A101-R01 Page 6 of 8 Photo 11 Test position bottom side without any distance cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-10_TR1-A101-R01 Page 7 of 8 Document History End of document ReleaseApplied changesRelease date R01initial releaseMarch 20, 2026 cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-10_TR1-A101-R01 Page 8 of 8

 

Annex A103 - Photographs No. 1-1438-25-01-01_TR1-A103-R01 April 29, 2026 DescriptionTest setup photos This document is electronically signed and valid without handwritten signature. Public keys for verifcation of the electronic signatures can be requested at the testing laboratory. Michael Dorongovski Lab Manager/ Telecommunication Certification Body (USA/CAN/ JPN) Regulatory Services Radio / Assessment &Approvals authorized by cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-01_TR1-A103-R01 Page 1 of 7 Photo 1 Photo 2 cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-01_TR1-A103-R01 Page 2 of 7 Photo 3 Photo 4 cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-01_TR1-A103-R01 Page 3 of 7 Photo 5 Photo 6 cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-01_TR1-A103-R01 Page 4 of 7 Photo 7 Photo 8 cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-01_TR1-A103-R01 Page 5 of 7 Photo 9 cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-01_TR1-A103-R01 Page 6 of 7 Document History End of document ReleaseApplied changesRelease date R01initial releaseApril 29, 2026 cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-1438-25-01-01_TR1-A103-R01 Page 7 of 7

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TEST REPORT Test report no.: 1-1438-25-01-04_TR1-R03 Testing laboratory Applicant cetecom advanced GmbH Untertuerkheimer Strasse 6 – 10 66117 Saarbruecken / Germany Phone: + 49 681 5 98 - 0 Fax: + 49 681 5 98 - 9075 Internet: https://cetecomadvanced.com e-mail: [email protected] Accredited Testing Laboratory: The testing laboratory (area of testing) is accredited according to DIN EN ISO/IEC 17025 (2018-03) by the Deutsche Akkreditierungsstelle GmbH (DAkkS). The accreditation is valid for the scope of testing procedures as stated in the accreditation certificate with the registration number: D-PL-12047-01-00. ISED Testing Laboratory Recognized Listing Number: DE0001 FCC designation number: DE0002 Roche Diagnostics GmbH Sandhofer Str. 116 68305 Mannheim / GERMANY Phone: +49 621 759-3409 Contact: Charaf Bnouachir e-mail: [email protected] Manufacturer Roche Diagnostics GmbH Sandhofer Str. 116 68305 Mannheim / GERMANY Test standard/s FCC - Title 47 CFR Part 15 FCC - Title 47 of the Code of Federal Regulations; Chapter I; Part 15 - Radio frequency devices RSS - 247 Issue 4 Digital Transmission Systems, Frequency Hopping Systems and Licence-Exempt Local Area Network Devices in 902-928 MHz, 2400-2483.5 MHz, 5150-5350 MHz, and 5470-5895 MHz bands For further applied test standards please refer to section 3 of this test report. Test Item Kind of test item: Medical Device Model name: AccuChek Inform II FCC ID: VO9-ACI2PAN9028 ISED certification number: 3100B-ACI2PAN9028 Frequency: 2400 MHz to 2483.5 MHz Technology tested: WLAN Antenna: Integrated antenna Power supply: 3.7 V DC by battery Temperature range: 0°C to +40°C This test report is electronically signed and valid without handwritten signature. For verification of the electronic signatures, the public keys can be requested at the testing laboratory. Test report authorized: Test performed: On behalf of Marco Bertolino René Oelmann Supervisor Radio Lab Lab Manager Regulatory Services Radio Regulatory Services Radio Test report no.: 1-1438-25-01-04_TR1-R03 © cetecom advanced GmbH Page 2 of 51 1 Table of contents 1 Table of contents .................................................................................................................................... 2 2 General information ................................................................................................................................ 3 2.1 Notes and disclaimer .................................................................................................................... 3 2.2 Application details .................…

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