2AYCW-EZLInsulin pen

01-2021 IFU_MAL_US_V1.13 Instructions For Use ® Designed for Flexpen ® Novo Nordisk Designed for Kwikpen ® Eli Lilly Designed for Solostar ® Sanofi Embedded software versions 3.6. and over Helping you keep track of your insulin doses IFU_MAL_US_V1.13_January 2021 P a g e 2 | 44 TABLE OF CONTENTS P. SYMBOLS IN THESE INSTRUCTIONS FOR USE ................................................................................... 4 STORAGE .................................................................................................................................................. 4 WARNINGS & CAUTIONS ........................................................................................................................ 5 FCC STATEMENTS ................................................................................................................................... 6 0. DIRECTIONS FOR USE .................................................................................................................... 7 0.1 FEATURES ............................................................................................................................... 7 0.2 INTENDED USE ........................................................................................................................ 7 1. MALLYA COMPATIBILITIES WITH PENS ....................................................................................... 8 2. GETTING TO KNOW YOUR MALLYA DEVICE ............................................................................... 9 2.1 GETTING STARTED ................................................................................................................. 9 2.2 FEATURES OF YOUR MALLYA ............................................................................................. 10 2.3 WEIGHT AND SIZE OF THE MAIN ELEMENTS .................................................................... 10 2.4 STORAGE INFORMATION ..................................................................................................... 10 2.5 TRANSPORT AND PACKAGING ........................................................................................... 11 3. INSTALLING THE MALLYA APPLICATION .................................................................................. 11 3.1 TECHNICAL COMPATIBILITIES ............................................................................................ 11 3.2 DOWNLOAD THE MALLYA APPLICATION AND GET STARTED ........................................ 12 4. CARING FOR YOUR MALLYA ....................................................................................................... 13 4.1 CHARGING YOUR MALLYA .................................................................................................. 13 4.2 CALIBRATING YOUR MALLYA .............................................................................................. 14 4.3 ATTACHING YOUR MALLYA TO PEN ................................................................................... 15 4.3.1 ATTACHING BASE TO PEN ................................................................................................... 15 4.3.2 ATTACHING KNOB TO PEN .................................................................................................. 15 4.4 PAIRING YOUR MALLYA ....................................................................................................... 17 5. USING YOUR INSULIN PEN WITH MALLYA ................................................................................ 19 5.1 SECURITY TEST - PRIMING ................................................................................................. 19 5.2 INJECTION .............................................................................................................................. 20 6. MANAGING RECORDED DATA ..................................................................................................... 21 6.1 DISPLAY OF THE RECORDED DATA .................................................................................. 21 6.2 MANAGE YOUR RECORDED DATA .................................................................................... 22 6.2.1 YOU CAN CHANGE A «PRIMING» OR A «DOSE» QUANTITY ALREADY RECORDED 22 6.2.2 YOU CAN CHANGE AN INJECTION RECORDED AS A «DOSE» TO A «PRIMING», OR A «PRIMING» TO A «DOSE» ............................................................................................................. 22 6.2.3 YOU CAN DELETE A «DOSE» OR A «PRIMING» ............................................................ 23 6.2.4 YOU CAN ADD AN INJECTION THAT WAS NOT RECORDED TO THE HISTORY........ 23 6.2.5 YOU CAN FILL IN A DOSE THAT WAS NOT CAPTURED BY THE DEVICE .................. 24 7. OTHER FEATURES OF THE MALLYA APPLICATION ................................................................ 24 7.1 GENERATE A REPORT ......................................................................................................... 24 7.2 PAIR TWO MALLYA TO YOUR MOBILE APP. ...................................................................... 25 7.3 SETTINGS ............................................................................................................................... 26 7.4 “HELP” SCREEN ..................................................................................................................... 27 IFU_MAL_US_V1.13_January 2021 P a g e 3 | 44 8. TRANSFERRING MALLYA TO A NEW PEN ................................................................................. 28 8.1 REMOVING MALLYA FROM THE EMPTY PEN .................................................................... 28 8.2 TRANSFERRING MALLYA TO A NEW PEN WITH SELECTING THE “MOVE MALLYA TO A NEW PEN” BUTTON ............................................................................................................................ 28 8.3 TRANSFERRING MALLYA TO A NEW PEN WITHOUT SELECTING THE “MOVE MALLYA TO A NEW PEN” BUTTON .....................................…

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01-2021 IFU_EMB_AD_US-CA-EN_V2 Instructions For Use Designed for Solostar ® Sanofi Embedded software versions 3.6. and over medical device Helping you keep track of your insulin doses IFU_EMB_AD_US-CA-EN_V2 TABLE OF CONTENTS 1. GENERAL INFORMATION ...........................................................................................................3 2. EMBODY COMPATIBILITIES – MOLECULES AND CONCENTRATIONS ................................3 3. DEVICE DESCRIPTION AND EXAM ENVIRONMENT ................................................................4 3.1 DEVICE DESCRIPTION ......................................................................................................4 EMBODY CHARACTERISTICS ...................................................................................4 ESSENTIAL PERFORMANCES OF THE SYSTEM (SIGNIFICANT OPERATING CHARACTERISTICS) ...............................................................................................................4 EMBODY PARTS REFERENCES ...............................................................................4 3.2 WEIGHT AND SIZE OF THE MAIN ELEMENTS ................................................................5 4. SAFETY INFORMATION ................................................................................................................5 4.1 SYMBOLS ON THE DEVICE AND / OR ITS PACKAGING ...............................................5 4.2 WARNINGS AND CAUTIONS ............................................................................................6 4.3 ELECTRICAL SAFETY .......................................................................................................7 4.4 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS .............8 4.5 EMBODY BASE AND BUTTON LABELING ......................................................................8 4.6 TRANSPORT AND STORAGE CONDITIONS ...................................................................9 4.7 USAGE CONDITIONS .........................................................................................................9 4.8 DISPOSAL ...........................................................................................................................9 5. UNPACKING AND INSTALLING EMBODY (CHARGING / CALIBRATING / ASSEMBLING / PAIRING) ............................................................................................................................................... 10 5.1 UNPACKING YOUR EMBODY AND ITS ACCESSORIES ............................................. 10 5.2 CHARGING AND CALIBRATING YOUR EMBODY ....................................................... 11 5.3 ASSEMBLING YOUR EMBODY TO THE INSULIN PEN................................................ 13 5.4 OPERATING IN AUTONOMOUS MODE OR IN PAIRING MODE .................................. 14 6. OPERATING INSTRUCTIONS ................................................................................................... 15 6.1 SECURITY TEST - PRIMING ........................................................................................... 15 6.2 INJECTION ....................................................................................................................... 16 7. AFTER USE INSTRUCTIONS: DISASSEMBLE EMBODY FROM PEN .................................... 17 8. TROUBLESHOOTING ................................................................................................................. 18 8.1 TROUBLESHOOTING EMBODY: VISUAL AND AUDITIVE BASE SIGNALS .............. 18 8.2 RESET INSTRUCTIONS .................................................................................................. 20 9. MAINTENANCE AND INSPECTION .......................................................................................... 20 9.1 EMBODY DEVICE LIFETIME .......................................................................................... 20 9.2 CLEANING YOUR EMBODY ........................................................................................... 20 9.3 MAINTAIN WATER, DUST AND LIGHT RESISTANCE ................................................. 21 10. TECHNICAL SPECIFICATIONS & PERFORMANCE ............................................................... 22 10.1 ELECTRICAL RATINGS .................................................................................................. 22 10.2 MATERIALS ..................................................................................................................... 22 10.3 ACCURACY ...................................................................................................................... 22 11. ELECTROMAGNETIC COMPATIBILITY ................................................................................... 23 11.1 GENERAL PRECAUTIONS AND WARNINGS ............................................................... 23 11.2 ELECTROMAGNETIC EMISSIONS ................................................................................. 23 11.3 INTERFERENCE IMMUNITY ........................................................................................... 24 11.4 ELECTROMAGNETIC IMMUNITY ................................................................................... 26 12. DISCLAIMER .............................................................................................................................. 27 IFU_EMB_AD_US-CA-EN_V2 TABLES LIST TABLE 1 - SYMBOLS USED IN IFU ....................................................................................................................... 2 TABLE 2 - ABBREVIATIONS LIST .......................................................................................................................... 2 TABLE 3 - EMBODY COMPATIBILITIES – MOLECULES AND CONCENTRATIONS ........................................... 3 TABLE 4 - EMBODY PARTS NUMBERS ................................................................................................................ 4 TABLE 5 - PARTS NECESSARY FOR OPERAT…

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CONFIDENTIALITY REQUEST Bureau Veritas Consumer Products Services Inc. One Distribution Center Circle #1 Littleton, MA 01460 USA March 31, 2021 Re: Confidentiality request FCC ID: 2AYCW-EZL Gentlemen, BIOCORP requests, pursuant to 47CFR 0.457(d) and 0.459, post grant confidentiality for portions of the material contained in this application. The following document regarding this submission for FCC ID: 2AYCW-EZL shall be kept confidential: LONG-TERM CONFIDENTIALITY: 1. Schematic Diagram of the equipment (file: Schematic - 2AYCW-EZL.pdf) 2. Block Diagram description of the equipment (file: Block Diagram - 2AYCW-EZL.pdf) 3. Operational description of the equipment (file: Operational Description - 2AYCW-EZL.pdf) Specifically, these exhibits contain information relating to circuit function and complexity that could be of benefit to competitors. The material contains trade secrets and confidential information that BIOCORP does not customarily release to the public and which is otherwise not generally available to the public. Regards, Responsible party: Alexia GARIN Title: VP QUALITY & REGULATORY AFFAIRS Signature:

Letter of Agency February 5, 2021 To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046-1609 Curtis-Straus LLC TCB One Distribution Center Circle #1 Littleton, MA 01460 We, the undersigned BIOCORP hereby authorize Anthony MERLIN, LCIE SUD EST, to act on our behalf in all matters relating to all processes required for FCC certification of our devices. Any and all acts carried out by the above agent on our behalf shall have the same effects as acts of our own. This authorization is valid until: April 1st, 2021 If you have any questions regarding this authorization, let us know please. Sincerely, Alexia GARIN Signature

LCIE SUD EST Laboratoire de Moirans Z.I. Centr’Alp 170, Rue de Chatagnon 38430 MOIRANS – France Page 1/3 EXTERNAL PHOTOS OF EQUIPMENT FCCID: 2AYCW-EZL Model : 027377-SLST / 0273790-SLST LCIE SUD EST Laboratoire de Moirans Z.I. Centr’Alp 170, Rue de Chatagnon 38430 MOIRANS – France Page 2/3 Model 0273694-KWKP LCIE SUD EST Laboratoire de Moirans Z.I. Centr’Alp 170, Rue de Chatagnon 38430 MOIRANS – France Page 3/3 Model 0273778-FLXP

LCIE SUD EST Laboratoire de Moirans Z.I. Centr’Alp 170, Rue de Chatagnon 38430 MOIRANS - FRANCE Page 1/1 PRODUCT LABELING FCCID: 2AYCW-EZL

LCIE SUD EST Laboratoire de Moirans Z.I. Centr’Alp 170, Rue de Chatagnon 38430 MOIRANS – France Page 1/1 INTERNAL PHOTOS OF EQUIPMENT FCCID: 2AYCW-EZL RF ANTENNA

LCIE SUD EST Laboratoire de Moirans Z.I. Centr’Alp 170, Rue de Chatagnon 38430 MOIRANS – FRANCE RF Exposure Considerations for FCC ID: 2AYCW-EZL Per FCC KDB 447498 D01 General RF Exposure Guidance v06 The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz are based on source-based time-averaged maximum conducted output power of the RF channel requiring evaluation, adjusted for tune-up tolerance, and the minimum test separation distance required for the exposure conditions. The minimum test separation distance defined in 4.1 f) is determined by the smallest distance from the antenna and radiating structures or outer surface of the device, according to the host form factor, exposure conditions and platform requirements, to any part of the body or extremity of a user or bystander. Minimum test separation distance: 5 mm Step a) For 100 MHz to 6 GHz and test separation distances ≤ 50 mm The 1-g and 10-g SAR test exclusion thresholds are determined by the following: (max푝표푤푒푟표푓 푐ℎ푎푛푛푒푙 ( 푚푊 ) ) (min푡푒푠푡푠푒푝푎푟푎푡푖표푛 푑푖푠푡푎푛푐푒 ( 푚푚 ) ) × √ 푓 ( 퐺퐻푧 ) ≤3.0 푓표푟 1−푔 푆퐴푅 표푟 ≤7.5 푓표푟 10−푔 푒푥푡푟푒푚푖푡푦 푆퐴푅 Where:  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation31  The result is rounded to one decimal place for comparison  The values 3.0 and 7.5 are referred to as numeric thresholds in step b) below The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm, and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. (dBm) (mW) Min 2.402 -8.4 0.14 5 0.04 3 7.5 Exempt from SAR Mid 2.442 -9 0.13 5 0.04 3 7.5 Exempt from SAR Max 2.480 -10.2 0.10 5 0.03 3 7.5 Exempt from SAR Limit for 10-g extremity SAR Verdict Maximum source-based time averaged conducted output power or EIRP (worst case) including tune-up tolerance Channel Frequency (GHz) Minimum separation distance (mm) Result of Eq. 1 Limit for 1-g SAR Conclusion: Therefore our device complies with FCC’s RF radiation exposure limits for general population without SAR evaluation.

Bluetooth Low Energy Template: Release November 03 rd , 2020 This document shall not be reproduced, except in full, without the written approval of the LCIE. This document contains results related only to the items tested. It does not imply the conformity of the whole production to the items tested. . Unless otherwise specified or rule defined by the test method, the decision of conformity doesn’t take into account the uncertainty of measures.This document doesn’t anticipate any certification decision. TEST REPORT N°: 169466-757152-A (FILE#1053664) Version : 03 Subject Radio spectrum matters tests according to standards: 47 CFR Part 15.247 & RSS-247 Issue 2 & RSS-Gen Issue 5 Issued to BIOCORP PARC TECHNOLOGIQUE DE LAVAUR - LA BECHADE 63500 – ISSOIRE FRANCE Apparatus under test  Product Insulin pen  Trade mark BIOCORP  Manufacturer BIOCORP  Family range 0273694-KWKP / 0273778-FLXP / 027377-SLST / 0273790-SLST  Model under test 027377-SLST  Serial number Sample 2&1  FCC ID 2AYCW-EZL  IC 26747-EZL Conclusion See Test Program chapter Test date December 16, 2020 to December 18, 2020 Test location Moirans FCC Test site FR0008 ISED Test Site FR0008 – 6500A Test Site 6500A-1 & 6500A-3 Sample receipt date December 16, 2020 Composition of document 38 pages Document issued on December 18, 2020 Written by : Approved by : Mounir BOUAMARA Anthony MERLIN Tests operator Technical manager TEST REPORT N° 169466-757152-A Version : 03 Page 2/38 PUBLICATION HISTORY Version Date Author Modification 01 December 18, 2020 Mounir BOUAMARA Creation of the document 02 December 18, 2020 Mounir BOUAMARA Adding FCC/IC informations 03 December 18, 2020 Mounir BOUAMARA Correcting the CP from 63800 to 63500 Add of the following informations FCC Test site FR0008 ISED Test Site FR0008 – 6500A Changed the value of the call_due of the the following equipements : the identifier A5329706 to 02/21 the identifier A1240251 to 01/21 Each new edition of this test report replaces and cancels the previous edition. The control of the old editions of report is under responsibility of client. TEST REPORT N° 169466-757152-A Version : 03 Page 3/38 SUMMARY 1. TEST PROGRAM ............................................................................................................................... 4 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) ................................ 5 3. OCCUPIED BANDWIDTH ................................................................................................................. 11 4. 6DB EMISSION BANDWIDTH .......................................................................................................... 14 5. MAXIMUM CONDUCTED OUTPUT POWER ................................................................................... 17 6. POWER SPECTRAL DENSITY ........................................................................................................ 21 7. UNWANTED EMISSIONS INTO NON-RESTRICTED FREQUENCY BANDS AT THE BAND EDGE 24 8. UNWANTED EMISSIONS INTO NON-RESTRICTED FREQUENCY BANDS ................................... 27 9. UNWANTED EMISSIONS IN RESTRICTED FREQUENCY BANDS ................................................ 30 10. UNCERTAINTIES CHART ................................................................................................................ 38 TEST REPORT N° 169466-757152-A Version : 03 Page 4/38 1. TEST PROGRAM References  47 CFR Part 15.247  RSS 247 Issue 2  RSS Gen Issue 5  KDB 558074 D01 DTS Meas Guidance v05r02  ANSI C63.10-2013 Radio requirement: Clause (47CFR Part 15.247 & RSS-247 Issue 2 & RSS-Gen Issue 5) Test Description Test result - Comments Occupied Bandwidth  PASS  FAIL  NA  NP(1) 6dB Bandwidth  PASS  FAIL  NA()  NP(1) Duty Cycle  PASS  FAIL  NA  NP(1) Maximum Conducted Output Power  PASS  FAIL  NA  NP(1) Power Spectral Density  PASS  FAIL  NA  NP(1) Conducted Spurious Emission at the Band Edge  PASS  FAIL  NA()  NP(1) Unwanted Emissions into Non-Restricted Frequency Bands  PASS  FAIL  NA()  NP(1) AC Power Line Conducted Emission  PASS  FAIL  NA(2)  NP(1) Unwanted Emissions into Restricted Frequency Bands  PASS  FAIL  NA  NP(1) Receiver Radiated emissions  PASS  FAIL  NA  NP(1) This table is a summary of test report, see conclusion of each clause of this test report for detail. (1): Limited program (2): EUT not directly or indirectly connected to the AC Power Public Network PASS: EUT complies with standard’s requirement FAIL: EUT does not comply with standard’s requirement NA: Not Applicable NP: Test Not Performed TEST REPORT N° 169466-757152-A Version : 03 Page 5/38 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) 2.1. HARDWARE IDENTIFICATION (EUT AND AUXILIARIES): Equipment under test (EUT): BIOCORP 027377-SLST Serial Number: Sample 2&1 Equipment Under Test Power supply: During all the tests, EUT is supplied by V nom : 5VDC For measurement with different voltage, it will be presented in test method. Name Type Rating Reference / Sn Comments Internal  AC  DC  Battery 3.7VDC - Lithium Supply  AC  DC  Battery 5VDC - - Inputs/outputs - Cable: Access Type Length used (m) Declared <3m Shielded Under test Comments 1 Micro USB 1.5    Power supply only Auxiliary equipment used during test: Type Reference Sn Comments Laptop Lenovo L460 - - Configuration carte ARM mbed - Used for the configuration of the product TEST REPORT N° 169466-757152-A Version : 03 Page 6/38 Equipment information: Bluetooth LE Type:  BLE  v4.1  v4.2  v5.0 Frequency band: [2400 – 2483.5] MHz Spectrum Modulation:  DSSS (Tested like it) Number of Channel: 40 Spacing channel: 2MHz Channel bandwidth:  1MHz  2MHz Antenna Type:  Integral  External  Dedicated Antenna connector:  Yes  No  Temporary for test Transmit chains: 1 Single antenna Gain: 0.5dBi Antenna requirements §15.203 The transmitter uses an integral antenna and it permanently connected. Therefore, the transmitter meets the requirements of…

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LCIE SUD EST Laboratoire de Moirans Z.I. Centr’Alp 170, Rue de Chatagnon 38430 MOIRANS - FRANCE Page 1/1 CONDUCTED AND RADIATED MEASUREMENT PHOTO FCCID: 2AYCW-EZL 1.1 Radiated emissions Photo Setup : anechoic chamber (XY axis) Photo Setup – OATS