FCC ID: 2AYCW-EZL Insulin pen

Instructions For Use 01-2021 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. 2. 3. GENERAL INFORMATION ...........................................................................................................3 EMBODY COMPATIBILITIES MOLECULES AND CONCENTRATIONS ................................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 9. 6. 5.4 OPERATING IN AUTONOMOUS MODE OR IN PAIRING MODE .................................. 14 OPERATING INSTRUCTIONS ................................................................................................... 15 6.1 SECURITY TEST - PRIMING ........................................................................................... 15 INJECTION ....................................................................................................................... 16 6.2 7. AFTER USE INSTRUCTIONS: DISASSEMBLE EMBODY FROM PEN .................................... 17 TROUBLESHOOTING ................................................................................................................. 18 8. 8.1 TROUBLESHOOTING EMBODY: VISUAL AND AUDITIVE BASE SIGNALS .............. 18 8.2 RESET INSTRUCTIONS .................................................................................................. 20 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 OPERATION ............................................................................................. 5 TABLE 6 - WEIGHT AND SIZE OF THE MAIN ELEMENTS ................................................................................... 5 TABLE 7 - SYMBOLS ON THE DEVICE AND ITS PACKAGING ............................................................................ 5 TABLE 8 - SYMBOLS ON THE DEVICE AND ITS PACKAGING (NEXT) ............................................................... 6 TABLE 9 - MAINS STANDARDS & CLASSIFICATION ........................................................................................... 8 TABLE 10 - EMBODY BASE AND BUTTON LABELING ........................................................................................ 8 TABLE 11 - TRANSPORT AND STORAGE CONDITIONS ..................................................................................... 9 TABLE 12 - USAGE CONDITIONS ......................................................................................................................... 9 TABLE 13 - PACKAGE CONTENT ....................................................................................................................... 10 TABLE 14 - TROUBLESHOOTING - VISUAL AND AUDITIVE BASE SIGNALS .................................................. 18 TABLE 15 - EMBODY ELECTRICAL INFORMATION .......................................................................................... 22 TABLE 16 - BATTERY CHARGING INFORMATION ............................................................................................ 22 TABLE 17 - MATERIALS ....................................................................................................................................... 22 TABLE 18 - ACCURACY ON TEST BENCH ......................................................................................................... 22 TABLE 19 - EXTERNAL FACTORS AND ACCURACY OF THE DISPLAYED VALUE ......................................... 22 TABLE 20 - ELECTROMAGNETIC EMISSIONS .................................................................................................. 23 TABLE 21 - INTERFERENCE IMMUNITY............................................................................................................. 24 TABLE 22 - RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE & RF ................................... 25 TABLE 23 - ELECTROMAGNETIC IMMUNITY ..................................................................................................... 26 IFU_EMB_AD_US-CA-EN_V2 SYMBOLS USED IN THIS MANUAL SYMBOL MEANING EXPLANATION WARNING CAUTION Improper operation may result in serious injury*1 or death to the user, patient Improper operation may result in bodily injury*2 or property damage*3 CAUTION Disconnect the device from power supply before servicing/cleaning NOTE Important information for operation Table 1 - Symbols used in IFU

*1 Serious injury means electrical shock or poisoning that causes a subsequent complication or requires hospitalization or long-term outpatient treatment.

*2 Bodily injury means an injury, burn, electrical shock and so on that will not necessitate hospitalization or long-

term outpatient treatment.

*3 Damage to property means extensive damage to a house and/or household goods as well as a domestic animal and pet. ABBREVIATIONS LIST Abbreviation Definition PN SN LED IP BLE Part Number Serial Number Light indicator

(Light Emitting Diode) Ingress Protection Bluetooth Low Energy Table 2 - Abbreviations list IFU_EMB_AD_US-CA-EN_V2 STATEMENTS (US) EMBODY Model: 0273790-SLST FCC ID: 2AYCW-EZL CAUTION:

- This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

- The user that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

- This device complies with FCC radiation exposure limits set forth for general population. This device must not be co-located or operating in conjunction with any other antenna or transmitter. NOTE:

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on, the user is encouraged to try to correct interference by one or more of the following measures:

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

- Connect the equipment into an outlet on circuit different from that to which the receiver is connected.

- Consult the dealer or an experienced radio/TV technician for help. STATEMENTS (CANADA) EMBODY Model: 0273790-SLST IC: 26747-EZL CAUTION:

- This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-exempt RSS(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) This device must accept any interference, including interference that may cause undesired operation of the device.

- This device complies with ISED radiation exposure limits set forth for general population. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Page 1 / 27 IFU_EMB_AD_US-CA-EN_V2 Device features The EMBODY device is composed of a base and a button that can be mounted on an insulin pen. Embody button Embody base The EMBODY device allows you to:

- Signal the end of an injection,

- Record the injected selected increment (insulin dose),

- Record the day and time when each insulin dose was injected,

- Transmit the dose, day/time of when each insulin dose was injected, to a compatible mobile application on a smartphone, when the EMBODY device is paired to it, thanks to Bluetooth technology. Pairing the EMBODY device with a compatible mobile application (autonomous software installed on a smartphone) will allow you to:

Improve adherence to your insulin treatment. EMBODY will allow you to keep accurate records of your insulin injections (dose, day/time of the injection),

- Generate a report showing the injected doses for a given period,

- Store and share your data with a healthcare provider. You can also use EMBODY in an autonomous mode (without a mobile application) to:

- Signal the end of your injections In this case, data cannot be displayed and cannot be shared with another person. Intended use EMBODY is intended to be used for the capture and wireless transmission of dosing information from compatible pen injectors. Intended users The intended users of the EMBODY device are patients with type I and II diabetes. EMBODY is a reusable device intended for a single patient. The EMBODY device is intended for use in a medical office or at home. Usage environment Healthcare data protection The terms of the regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 may apply to the interactions between Biocorp Production and users of its products. To this end, Biocorp Production agrees to comply with its obligations in accordance with the regulation applicable to Personal data protection and makes every effort to guarantee the security, confidentiality, and integrity of the Personal data that it may process. A user has the right to access their data, rectify them, request their deletion, or exercise their right to limit the processing of such data. They may withdraw their consent to the processing of such data at any time; they may also object to the processing of their data and exercise their right to the portability of such data. To exercise these rights, please contact: gdpr@biocorp.fr If a user considers, after having contacted Biocorp Production, that their Data Protection and Privacy rights have not been respected or that the access control provision does not comply with data protection rules, such user may file a claim online or by mail with the relevant national data protection authority. Page 2 / 27 IFU_EMB_AD_US-CA-EN_V2 1. GENERAL INFORMATION BIOCORP PRODUCTION ZI LAVAUR LA BECHADE 63500 ISSOIRE CEDEX FRANCE DISTRIBUTOR:

See list at the end of leaflet The user manual must be accessible to you at all times. You must read all instructions carefully before using the device. If you have technical problems with our product, please contact a BIOCORP PRODUCTION authorized dealer. The following information will be needed in order to provide you with the necessary assistance:

Serial Number of your EMBODY unit (this SN number can be found on the device COMPATIBILITIES MOLECULES AND label) 2. EMBODY CONCENTRATIONS WARNING Make sure EMBODY is compatible with your pen (insulin type and concentration). The molecules and associated concentrations compatible with the EMBODY device are listed in the table below:

EMBODY MODEL INSULINE INN CONCENTRATION EMBODY designed for SOLOSTAR SANOFI insulin pen GLARGINE LISPRO GLULISINE GLARGINE AND LIXISENATIDE 100 IU/mL 300 IU/mL 100 IU/mL 100 IU/mL 100 IU/mL

+33 mcg/mL Table 3 - EMBODY compatibilities Molecules and concentrations WARNING EXCLUDED VERSIONS EMBODY IS NOT COMPATIBLE WITH THE FOLLOWING INSULIN PENS:

Toujeo Max Toujeo Doublestar Page 3 / 27 IFU_EMB_AD_US-CA-EN_V2 3. DEVICE DESCRIPTION AND EXAM ENVIRONMENT 3.1 DEVICE DESCRIPTION EMBODY CHARACTERISTICS The EMBODY device is composed of a base and a button:

Micro USB port BASE BUTTON LED Clear square dose window Button ESSENTIAL PERFORMANCES OF THE SYSTEM (SIGNIFICANT OPERATING CHARACTERISTICS) The essential performance characteristic for the EMBODY device has been defined as follows:

Provide reliable data dosage parameters of a drug to the patient and caregivers. The device sends treatment information via Bluetooth (BLE) to the patients smartphone:

A compatible mobile application allows the patient to securely display treatment information. This improves the patients therapeutic adherence. Injected Insulin Dosage (UI) Injection Date Injection Hour EMBODY PARTS REFERENCES The references (Part Numbers) vary depending on the EMBODY model:

EMBODY MODEL EMBODY BASE APPLIED PART EMBODY BUTTON APPLIED PART EMBODY designed for SOLOSTAR SANOFI insulin pen PN : 0273790 Table 4 - EMBODY parts numbers PN: 0273710 Page 4 / 27 IFU_EMB_AD_US-CA-EN_V2 The following parts are necessary to operate the EMBODY device:

USB CABLE RESET KEY PN: 0373707 PN: 0373708 Table 5 - Parts necessary for operation 3.2 WEIGHT AND SIZE OF THE MAIN ELEMENTS ELEMENT WEIGHT INSULIN PEN SIZE EMBODY base 0,016 kg SOLOSTAR

(60.8x26.9x21.3) mm EMBODY button 0,006 kg SOLOSTAR

(24.4 x 20) mm EMBODY total weight 0,022 kg

Table 6 - Weight and size of the main elements 4. SAFETY INFORMATION 4.1 SYMBOLS ON THE DEVICE AND / OR ITS PACKAGING SYMBOL LOCATION DESCRIPTION DEVICE AND PACKAGING DEVICE AND PACKAGING DEVICE AND PACKAGING DEVICE AND PACKAGING PACKAGING DEVICE AND PACKAGING Refer to the instructions for use Manufacturer Serial Number Manufacturing date PACKAGING Batch Number International and unique item code

(Global Trade Item Number) Product reference Table 7 - Symbols on the device and its packaging Page 5 / 27 IFU_EMB_AD_US-CA-EN_V2 SYMBOL LOCATION DEVICE DEVICE DESCRIPTION US - Operation is subject to the following 2 conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. CANADA - Innovation, Science and Economic Development Canada certification number (certification class A/B intentional radiator) PACKAGING Distributor reference PACKAGING Class II device (double isolation) PACKAGING Type BF applied part PACKAGING Protection index IP22 (see section 9.3.: maintain water, dust and light resistance) PACKAGING For indoor use only PACKAGING Moisture sensitive device PACKAGING Temperature limits to which the device can be safely exposed. PACKAGING Humidity limits to which the device can be safely exposed. PACKAGING Pressure limits to which the device can be safely exposed.

-) PACKAGING Management of electrical and electronic waste. Table 8 - Symbols on the device and its packaging (next) 4.2 WARNINGS AND CAUTIONS NOTES:

- EMBODY must only be used for the intended use described in this manual.

- Read these instructions before you use EMBODY for the first time. Keep these instructions in a safe place.

- The device must be used in the specified ambient conditions (do not expose the device

to temperatures above 40C (104F) or flames). If the device experiences an external mechanical impact (knocking, bumping, dropping, etc.), this may cause malfunctioning of the device. In case of malfunctioning, please contact a BIOCORP PRODUCTION authorized dealer for technical support.

- Never install a mobile application from unofficial stores on your phone.

- Using a phone of unknown origin causes risk and will invalidate the EMBODY warranty.

- Protect your personal health data by using a password on your smartphone.

- Periodic maintenance of EMBODY is not required, only daily inspection is recommended. Maintenance of the EMBODY is required when the device does not pass its functional testing. If the functional testing is not successful, you are prompted to contact a BIOCORP PRODUCTION authorized dealer. Page 6 / 27 IFU_EMB_AD_US-CA-EN_V2 WARNING

- If you are not certain that you injected your insulin, do not start or repeat your injection. Monitor your blood glucose as instructed by your healthcare provider.

- Disconnect the USB cable from the USB charging port and disconnect EMBODY from the USB cable before using it.

- EMBODY is supplied with a USB cable. Do not use any other cable. Use the cable supplied with the device to connect it to a USB power port.

- Do not attach or tighten cable to or around the head or neck. Cable can cause strangulation.

- Avoid using near PACEMAKERS and DEFIBRILLATORS.

- EMBODY contains a magnet, avoid contact with metallic parts during use.

- This device is not recommended for use by the blind or visually impaired without the help of someone trained to use the device.

- Do not disassemble, modify or repair the device by yourself. Otherwise, it may cause fire, electrical shock, bodily injury, or device malfunction. Refer all servicing to your authorized BIOCORP PRODUCTION dealer. The instrument disassembled, modified or repaired by anyone other than a BIOCORP PRODUCTION designated repair facility will invalidate the warranty. If there is any abnormal smell, sound, heat, or smoke when using the device, stop using EMBODY. Continued use may cause fire or device malfunction. Contact your authorized BIOCORP PRODUCTION dealer for inspection.

- EMBODY is not waterproof and will not be protected against the infiltration of water or moisture:

Do not immerse the device in water and do not clean it under running water. Do not expose the device to moisture.

- Do not place EMBODY in a microwave.

- Do not operate the device in a hazardous environment: presenting a risk of explosion, or containing volatile solvents (alcohol, etc.) or flammable substances (anaesthetics, etc.); or do not place it in the vicinity of an environment rich in OXYGEN.

- Small Children: Do not leave your EMBODY and its accessories within the reach of small children or allow them to play with it. They could hurt themselves or others or could accidentally damage the device. Your EMBODY contains small parts with edges that may cause injuries or may detach and create a choking hazard.

- Animals or insects: Do not leave your EMBODY and its accessories within the reach of animals or insects. After use, your device must then be put away in its original packaging.

- The use of accessories other than those specified for the device is not recommended. They may result in increased emissions or decreased electromagnetic immunity of the device. 4.3 ELECTRICAL SAFETY EMBODY is supplied with a USB cable. Do not use any other cable. Use the cable supplied with the device to connect it to a USB power port. CAUTION Connect the EMBODY USB cable to a power source compliant with the IEC 60601-1. Page 7 / 27 IFU_EMB_AD_US-CA-EN_V2 4.4 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS COMPLIANT STANDARDS DESCRIPTION CLASSIFICATION Protection type against electric shock Degree of protection against electric Class II (double isolation) Type BF IEC 60601-1 shock Mode of operation Continuous operation

* Refer to EMC section 11 IEC 60601-1-2 IEC 60529 Electromagnetic compatibility Type of protection against the access to hazardous parts and the infiltration of water as detailed in the current edition of IEC IP22 Table 9 - Mains standards & classification 4.5 EMBODY BASE AND BUTTON LABELING EMBODY TYPE US / CA BASE LABELING BUTTON MARKINGS

(INSIDE) EMBODY designed for SOLOSTAR SANOFI insulin pen US CA Table 10 - EMBODY base and button labeling NOTE:

The part number and serial number of the device can also be found on the packaging accompanying the device. Page 8 / 27 IFU_EMB_AD_US-CA-EN_V2 4.6 TRANSPORT AND STORAGE CONDITIONS Transport Storage Temperature 10C to +40C

(14F < T < 104F) 10C to +40C

(14F < T < 104F) Atmospheric pressure Relative humidity 500 hPa to 1060 hPa 10% to 90%

800 hPa to 1060 hPa 10% to 90%

Table 11 - Transport and storage conditions CAUTION from damage.

- The device must be transported and stored in its original packaging designed to protect it

- Storage and transport conditions must meet conditions described in the above table. 4.7 USAGE CONDITIONS Temperature

+15C to +35C

(59F < T < 95F) Operating 800 hPa to 1060 hPa 30% to 70%

Table 12 - Usage conditions Atmospheric pressure Relative humidity

- Leave the device in a room for 30 minutes before unpacking to ensure there is no CAUTION condensation. 4.8 DISPOSAL Dispose of EMBODY according to your local guidelines. According to Directives 2012/19/UE WEEE and 2011/65/UE RoHS II on the restriction of hazardous substances in electrical and electronic equipment on their disposal:

Public authorities adopt adequate measures to make sure that users, distributors and manufacturers contribute to the collection of electrical and electronic equipment, setting legal requirements to reuse, recover or recycle the said equipment. CAUTION You must take into account the potentially harmful effects to the environment or human health due to the improper disposal of the equipment or of parts of it. The following graphic symbol is applied on the label of the equipment:

It reminds that all electrical and electronic equipment must be collected and disposed of separately from domestic waste at the end of life. CAUTION Before disposing of EMBODY: reset the device to delete all your personal health data (see section 8.2.) Page 9 / 27 IFU_EMB_AD_US-CA-EN_V2 5. UNPACKING AND CALIBRATING / ASSEMBLING / PAIRING) INSTALLING EMBODY

(CHARGING

CAUTION

- EMBODY can only be paired with a compatible mobile application.

- EMBODY is only compatible with the insulin pens:

Solostar Sanofi (except for TOUJEO MAX and TOUJEO DOUBLESTAR) Refer to section 2 EMBODY compatibilities Molecules and concentrations 5.1 UNPACKING YOUR EMBODY AND ITS ACCESSORIES PACKAGE CONTENTS EMBODY base (x1) EMBODY button (x 2) USB Cable (x 1) Reset Key (x 1) Quick Start Guide with reference: QSG_EMB_EN (x 1) Table 13 - Package content UNPACKING STEP 1 Open the EMBODY shipping box EMBODY is packed for shipping / transportation in a cardboard box:

The internal cardboard housing with special shaped forms and cardboard parts supports the EMBODY base and the button. NOTES:

- After opening, keep all the original packaging for future use (in case of return or transport of the device). The device must always be transported in its original packaging, which has been specially designed to protect it from damage.

- Check whether the packaging is damaged. If damage is found, the device may also have been damaged. Please contact your distributor. Page 10 / 27 IFU_EMB_AD_US-CA-EN_V2 STEP 2 Remove from the box: the base, the button and the accessories You can get EMBODY free support @ my-EMBODY.com 5.2 CHARGING AND CALIBRATING YOUR EMBODY CHARGING YOUR EMBODY NOTE:

EMBODY must be charged before first-time use.

- EMBODY is supplied with a USB cable. Do not use any other cable. Use the cable supplied with the device to connect it to a USB power port.

- Never use your EMBODY for an injection while it is connected to a USB power port and CAUTION charging. Plug the powered USB cable into the EMBODY micro-USB port. Check that the EMBODY LED is slowly flashing green. Let the battery charge for at least 10 minutes. NOTES:

Fully recharging the battery takes approximately 2 hours. When the battery is fully charged, the green LED will turn off. You can then unplug the USB power cable. Optimal autonomy is reached when EMBODYs battery is fully charged. You can then use EMBODY for at least 2 weeks. Page 11 / 27 IFU_EMB_AD_US-CA-EN_V2 CALIBRATING YOUR EMBODY Disconnect the USB cable from the EMBODY base. Check that the EMBODY LED is flashing orange. Slowly tilt the EMBODY base side to side to CALIBRATE. Continue tilting until:

The base beeps and the LED light turns green. Then the light will turn off. NOTE:

If the orange LED does not light up after disconnecting the USB cable from the EMBODY base, it means that the calibration was done automatically. You can go directly to the next section:

Section 5.3. Assembling your EMBODY to the insulin pen. Page 12 / 27 IFU_EMB_AD_US-CA-EN_V2 5.3 ASSEMBLING YOUR EMBODY TO THE INSULIN PEN CAUTION The EMBODY base and button must be correctly attached onto the pen, otherwise, data will not be transferred. ATTACHING BASE TO PEN Hold the EMBODY base so that the clear square plastic window is facing you Align the EMBODY base clear square plastic window with the pen dose window, then snap the base onto the pen. Make sure the EMBODY base window is perfectly aligned with the pen dose window. NOTE:

A pen symbol is represented on the side of the EMBODY base to help you position the correct orientation (square window oriented toward the top of the pen). the pen in ATTACHING BUTTON TO PEN Align the EMBODY buttons grooves with the dose injection buttons notches, then insert the EMBODY button onto the pen injection button. Make sure the button is properly attached and fully inserted. The EMBODY base LED will flash orange and green when the button and base are properly mounted onto the pen and when the EMBODY device is not yet paired. Page 13 / 27 IFU_EMB_AD_US-CA-EN_V2 5.4 OPERATING IN AUTONOMOUS MODE OR IN PAIRING MODE EMBODY can:

Or

- Either operate in autonomous mode:

In this case, data cannot be displayed and cannot be shared with another person.

- Be paired with a compatible mobile application (an autonomous software installed on a smartphone). In this case, please follow the application manufacturers instructions to pair EMBODY and use the application. When EMBODY is paired and correctly attached to the injector pen: the LED is green. In pairing mode: EMBODY will track your activities CAUTION EMBODY must only be paired with a compatible application Page 14 / 27 IFU_EMB_AD_US-CA-EN_V2 6. OPERATING INSTRUCTIONS NOTE:

Once EMBODY is attached to the insulin pen, the pen should be used just like a normal insulin pen. Refer to the manufacturers injector pen user manual. 6.1 SECURITY TEST - PRIMING WARNING Always perform a priming (safety test) before each injection to ensure that:

Your pen and the needle are working properly, The right dose of insulin will be injected. If you do NOT perform the priming, you may receive too much or too little insulin (refer to the manufacturers injector pen user manual). IN AUTONOMOUS MODE OR PAIRING MODE => follow the steps indicated below:

Follow the injectable insulin pen instructions for use to carry out the priming step. At the end of the priming step, hold the injection button pressed down:

- While EMBODYs green LED is flashing,

- Until EMBODY emits an audible signal

(BEEP) signaling the end of the priming step. WARNING If the liquid does not come out of the needle tip during the safety test, do not use the pen and refer to the manufacturers injector pen instructions for use for more information to solve the problem. You can release the pressure on the button when the green LED stops flashing and the BEEP signaling the end of priming is emitted. IN PAIRING MODE ONLY When the device is coupled with a compatible mobile application installed on a smartphone:

The compatible application will automatically detect a priming if:

- You are priming 1 or 2 unit(s), AND

- You perform your insulin injection just after the priming step (within 2 minutes) NOTE :

Priming will not be displayed in the application right away: it will be displayed once the insulin injection is done, within 2 minutes after priming. Please refer to the application manufacturers instructions. CAUTION If the time interval between the two consecutive injections exceeds 2 minutes, the application will automatically detect an injection instead of a priming. Page 15 / 27 IFU_EMB_AD_US-CA-EN_V2 6.2 INJECTION WARNING If you are not certain that you injected your insulin, do not start or repeat your injection. Monitor your blood glucose as instructed by your healthcare provider. IN AUTONOMOUS MODE OR PAIRING MODE => follow the steps indicated below:

Check the insulin dose to inject according to the prescription and the type of Turn the button to select the number of units to inject. The dose indicator should medication. line up with the dose to inject. Press on the injection button with your thumb until you return to ZERO (complete dose injection) Keep the injection button pressed in and the needle in the skin:

- While the EMBODYs green LED is flashing,

- Until EMBODY emits an audible signal

(BEEP) signalling the end of the injection. You can release the pressure on the button and then remove the needle from the skin when the green LED stops flashing and the BEEP signaling the end of injection is emitted. WARNING If you do not see ZERO (0) in the pen dose window: it indicates that the full dose has not been injected. IN PAIRING MODE ONLY When the device is coupled with a compatible mobile application installed on a smartphone:

The application automatically detects an injection. The information corresponding to the injected dose is displayed: dose, day and time. Please refer to the application manufacturers instructions. COMPATIBLE MOBILE APP. SCREENS INFORMATION Refer to the manufacturers application instructions for use for more information regarding the functionalities of the application you are using. More particularly:

- To display the selected and injected insulin dose

- To display the date and time of each injection. Page 16 / 27 IFU_EMB_AD_US-CA-EN_V2 7. AFTER USE INSTRUCTIONS: DISASSEMBLE EMBODY FROM PEN Follow the procedure indicated below to disassemble EMBODY from your pen:

7.1 Remove the EMBODY base from the insulin pen. Use your thumb to press on EMBODY and to remove it from the pen. 7.2 Then, remove the EMBODY button from the pen. 7.3 Follow section 5. on assembling your EMBODY to the new insulin pen. NOTE :

It is not necessary to pair your EMBODY again when changing the pen (unless your system has been reset - see section 8.2. Reset instructions). CAUTION

- EMBODY models are only compatible with the disposable insulin pens (Solostar, Kwikpen, Flexpen) they are designed for. Do not attach to, pair or use with any other insulin pen types. If you need to inject more than the number of units left in the pen, you may either:

1) Inject the amount left in your pen and then use a new pen to deliver the rest of your

dose: the EMBODY application will then display 2 successive injections, or 2) Get a new pen and inject the full dose: the EMBODY application will display one full dose injection. CAUTION When EMBODY is transferred onto a new pen, the application automatically detects a mounting event (e.g..: your base and / or the button have / has been removed from the original pen). In this situation, follow the application manufacturers instructions to confirm the new pen type currently assembled with EMBODY. Page 17 / 27 IFU_EMB_AD_US-CA-EN_V2 8. TROUBLESHOOTING CAUTION

- Never attempt to access the internal hardware of the device.

- When a functional testing is not successful and if the given recommendations do not solve the issue, you are prompted to contact a BIOCORP PRODUCTION authorized dealer. 8.1 TROUBLESHOOTING EMBODY: VISUAL AND AUDITIVE BASE SIGNALS When a visual or audible signal occurs on your EMBODY, check the cause and follow the indications listed below to solve the issue:

SIGNAL CAUSE TROUBLESHOOTING STEPS Red LED Orange LED (rapid flashing) Alternating orange and green flashing (rapid flashing) Orange LED (slow flashing)

(every 15 seconds) Orange LED CAUTION EMBODY error Calibration in progress:

Remove EMBODY from pen. Re-calibrate EMBODY if the light indicator is flashing orange (see section 5.2.2.) If the issue persists and the light is still red: reset the system (see section 8.2.) Then, try to pair EMBODY to your smartphone (see section 5.4.) If the problem is not solved, please contact a BIOCORP PRODUCTION authorized dealer. Slowly tilt the EMBODY side to side to calibrate (see section 5.2.2.) A green light will appear for 2 seconds upon successful calibration (with a beep, then the green light will turn off). EMBODY device is correctly positioned onto the pen but must be paired. Pair EMBODY to your smartphone (see section 5.4.) Battery is low. Plug in and charge the EMBODY base

(see section 5.2.1.) EMBODY position error on pen, OR The button is not turned back to the dose 0 Make sure that:

the EMBODY window and the pen dose window are properly aligned, and the EMBODY button is correctly pushed onto the pen

(please see the cautions recommendations below this table)

OR

the button is turned back to the dose 0. Page 18 / 27 IFU_EMB_AD_US-CA-EN_V2 Table 14 - Troubleshooting - Visual and auditive base signals ORANGE LED TROUBLESHOOTING RECOMMENDATIONS The EMBODY base light indicator (LED) remains orange if:

the clear square plastic window of the EMBODY base and the dose window of the pen are not correctly aligned, or if the base is mounted too low / too high ( the top of the EMBODY base must be aligned with the top of the pen, at the base of the dose button on the pen), or

if the EMBODY button is not pushed on enough. In this case, it is necessary to:

- Adjust and align:

the position of the windows:

or raise or lower the position of the EMBODY base on the pen,

- Or, to push the EMBODY button onto the pen, until the EMBODY base LED flashes green and orange if EMBODY is not paired (if EMBODY is paired, the light indicator is green). Page 19 / 27 IFU_EMB_AD_US-CA-EN_V2 8.2 RESET INSTRUCTIONS The reset procedure of EMBODY may be necessary:

If EMBODY is not working properly (no response, etc), If you need to pair EMBODY with another mobile phone (smartphone), If you want to delete your personal health data from the device. PROCEDURE:

Disassemble EMBODY as indicated section 7. Flip EMBODY over so that you can see the following indications:

Take the Reset Key:

Insert the Reset Key into the hole shown below and WAIT until 3 beeps are emitted before removing the key. 3 BEEPS Then follow section 5. to prepare your device for a new operation. 9. MAINTENANCE AND INSPECTION 9.1 EMBODY DEVICE LIFETIME EMBODY and accessories expected lifetime is 2 YEARS. You are not required to perform a periodic maintenance of the device. 9.2 CLEANING YOUR EMBODY When the surface of EMBODY is dirty, follow the steps indicated below to clean it:

Disconnect the USB cable from EMBODY. Wipe the surface of the device with a slightly damp lint-free cloth. You can wipe off persistent dirt with a soft lint-free cloth slightly moistened with: water containing a small amount of neutral cleaning agent, or with ethanol 95%. Dry with a soft, lint-free cloth. Avoid moisture from reaching the micro-USB opening. WARNING Disconnect the USB cable before cleaning EMBODY. Page 20 / 27 IFU_EMB_AD_US-CA-EN_V2 CAUTION

- Do not wipe the surface of EMBODY with chemical products or solvents (e.g. acetone) other than those specified in this cleaning procedure as it could lead to discoloration or deterioration.

- Please remember that the EMBODY is not waterproof:

Do not immerse the device in water and do not clean it under running water. Do not expose the device to moisture. Do not use the device in the bathroom or in areas with high temperature, humidity, dust or rain.

- Do not share EMBODY with other people to prevent infection. 9.3 MAINTAIN WATER, DUST AND LIGHT RESISTANCE The device is rated IP22 using the Ingress Protection rating system. As defined in the IEC standard 60529, the IP code (or Ingress Protection code) classifies and rates the degree of protection provided by mechanical casing and electrical enclosure against the intrusion of solid objects, dust, accidental contact, and water. EMBODY is rated IP22 using this Ingress Protection rating system: your device has shown to be water and dust resistant in certain circumstances Despite this classification, your device is no manner impermeable to water damage. NOTE:

If any liquid is found to have entered your device components (inside the sealed system): your devices warranty will be void. Follow the next tips carefully to prevent damage to the device (operational or cosmetic issues):

- Whenever your device gets wet, dry it thoroughly with a soft, dry and clean cloth. You should dry the inside of the charging port before inserting a power connector to charge your device. If the charging port is not fully dry, your device may operate abnormally. For example, it may charge more slowly or overheat.

- Do not expose the device to direct sunlight.

If the device is dropped or receives an impact, its water and dust resistance may be impaired. Page 21 / 27 IFU_EMB_AD_US-CA-EN_V2 10. TECHNICAL SPECIFICATIONS & PERFORMANCE 10.1 ELECTRICAL RATINGS Make sure you connect the EMBODY USB cable to a power source compliant with the IEC 60601-1. CAUTION Input voltage Min Current Ingress Protection Battery USB CHARACTERISTICS 5V DC 2A 500mA IP 22 BATTERY CHARACTERISTICS Model Number Operating time with fully charged battery Charging time for fully charged battery Li-ion rechargeable :

Li-ion 3,7V-130mAh GEB401730 / FT401235P 2 weeks Full charge in 2.5 hours Table 15 - EMBODY electrical information You can connect the supplied USB cable to the USB port of your PC or to an AC adapter suitable for your region, with the following characteristics:

AC ADAPTOR (NOT PROVIDED) External Module with automatic adaptation of the voltage: no selection is required. Input voltage range Frequencies range Category Output voltage Output current 10.2 MATERIALS 90-264 V 47-63 Hz II (double insulation) 5V DC 500mA 2A Table 16 - Battery charging information EMBODY PART MATERIALS EMBODY base EMBODY button PC/ABS (cover) Copolyester (body) Polypropylne and POM TPE Table 17 - Materials 10.3 ACCURACY MEASUREMENT ACCURACY 99%

Table 18 - Accuracy on test bench CAUTION External factors may affect the dose measurement accuracy. Factors Affect the measurement Ambient Temperature Magnetic disturbance Table 19 - External factors and accuracy of the displayed value To display the accurate doses, please follow the recommended conditions of use. Does not affect the measurement Page 22 / 27 IFU_EMB_AD_US-CA-EN_V2 11. ELECTROMAGNETIC COMPATIBILITY 11.1 GENERAL PRECAUTIONS AND WARNINGS Electrical medical devices and systems are subject to special measures concerning electromagnetic compatibility (EMC) and must be installed in accordance with the EMC instructions contained in this enclosed document. Portable and mobile radiofrequency communication systems may interfere with electrical medical devices. The use of accessories and cables other than those supplied with the devices, with the exception of the cable sold by the equipment manufacturer as spare parts, may result in increased emissions and reduced device or system immunity. The device must not be used when it is in contact with other electro-medical devices. 11.2 ELECTROMAGNETIC EMISSIONS The device is intended for use in the following electromagnetic environment. You must ensure compliance with this guideline. GUIDANCE AND MANUFACTURERS DECLARATION ELECTROMAGNETIC EMISSIONS The EMBODY is intended for use in the electromagnetic environment specified below. The operator of the EMBODY should ensure that it is used in such an environment. Emission test Compliance Electromagnetic environment - Guidance Radiated RF emission acc. to CISPR 11 Group 1 Class B acc. RF to Conducted emissions CISPR 11 Harmonic acc. to IEC 61000-3-2 Voltage fluctuations /

Flicker emissions acc. To IEC 61000-3-3 emissions Group 1 Class A compliant compliant EMBODY uses RF energy only for its internal functions. Therefore, its RF emissions are very low and are not likely to impair nearby electronic equipment. EMBODY is suitable in all establishments other than those in residential areas and those directly connected to the public low voltage power supply network that also supplies buildings used for residential purposes. Table 20 - Electromagnetic emissions Page 23 / 27 IFU_EMB_AD_US-CA-EN_V2 11.3 INTERFERENCE IMMUNITY The device is intended for use in the following electromagnetic environment. You must ensure compliance with this guideline. GUIDANCE AND MANUFACTURER DECLARATION ELECTROMAGNETIC IMMUNITY The EMBODY is intended for use in the electromagnetic environment specified below. The operator of the EMBODY should ensure that it is used in such an environment. Immunity Test CEI 60601 test level Compliance level Conducted disturbances according 61000-4-6 RF to IEC Radiated disturbances according 61000-4-3 RF to IEC 3 Veff 150 kHz to 80 MHz Not applicable 10 V/m 80 MHz to 2,7 GHz 10 V/m mobile Electromagnetic environment -

Guidance and Portable RF communications equipment should be used no closer to any part of EMBODY, including cables, than the recommended separation distance calculated equation applicable to the frequency of the transmitter. Recommended distance:

separation from the Recommended separation distance This test is not applicable since the equipment has not power or input/output line d 2,1 P for 80 MHz to 800 MHz to P

(W) according 3,2 for 800 MHz to 2,5 d GHz Where P is the maximum emission output power of the transmitter in watts the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strength fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

from NOTE 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies. NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device EMBODY is used exceeds the applicable RF compliance level above, additional measures may be necessary, such as reorientation or relocating the EMBODY In case unusual performance is witnessed, additional measures may be required such as change of orientation or location of the EMBODY b Field strength should be less than 10 V/m in the range between 150 kHz and 80 MHz Table 21 - Interference immunity Page 24 / 27 IFU_EMB_AD_US-CA-EN_V2 EMBODY is intended for use in an electromagnetic environment where radiated RF disturbances are under control. You can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communication devices

(transmitters) and the EMBODY device as recommended below, according to the maximum output power of the radio communications devices RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND EMBODY EMBODY is intended for use in an electromagnetic environment in which the radiated RF disturbances are controlled. The EMBODY user can help prevent electromagnetic interference by maintaining a minimal distance between portable and mobile RF communications equipment (transmitters) and the EMBODY as recommended below, according to the maximum output power of the communications equipment. Separation distance according to the transmitters frequency (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5GHz Maximum transmitter power output (W) d d P 5,3 V 1 0,12 0,38 1,2 3,8 12 P 5,3 E 1 0,12 0,38 1,2 3,8 12 d 7 E 1 P 0,23 0,73 2,3 7,3 23 0,01 0,1 1 10 100 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum emission output power of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: Between 80 MHz and 800 MHz, separation distance for the highest frequency range applies NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Table 22 - Recommended separation distance between portable & RF Note: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this product is used exceeds the applicable RF compliance level above, this product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating this product. Page 25 / 27 IFU_EMB_AD_US-CA-EN_V2 11.4 ELECTROMAGNETIC IMMUNITY The device is intended for use in the following electromagnetic environment. You must ensure compliance with this guideline. GUIDANCE AND MANUFACTURER DECLARATION ELECTROMAGNETIC IMMUNITY The EMBODY is intended for use in the electromagnetic environment specified below. The operator of the EMBODY must ensure that it is used in such an environment. Immunity test CEI 60601 test level Compliance level Electromagnetic environment - Guidance Electrostatic discharge

(ESD) acc. To IEC 61000-4-2 Electrical fast transients/ burst acc. To IEC 61000-4-4

- 8 kV contact discharge

- 2 kV , 4 kV, 6 kV, 8 kV, 15 kV air discharge

- 2 kV/100Hz for power supply lines

- 8 kV contact discharge

- 2 kV, 4 kV, 6 kV, 8 kV, 15 kV air discharge 2 kV/100Hz for power supply lines Surge acc. To IEC 61000-4-5

- 0.5, 1 kV differential mode 0.5, 1 kV differential mode Voltage dips, short-

term interruptions and voltage variations on power supply input lines acc. to 61000-4-

11

<5% UT during 0,5 period 40% UT during 5 periods 70% UT during 25 periods

<5% UT during 5s Compliant to the specified levels Compliant Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic materials, the relative humidity should be at least 30%. The quality of the supply voltage should correspond with one characteristic for a typical commercial or hospital environment. The quality of the supply voltage should correspond with one characteristic for a typical commercial or hospital environment. The quality of the supply voltage should correspond to one characteristic for a typical commercial or hospital environment. If the user of the EMBODY requires a continuous function of the appliance also during interruptions of the power supply, it is recommended to power EMBODY out of an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic for commercial or hospital environments. 30 A/m 30 A/m NOTE: UT is the voltage of the alternative supply voltage before the application of the test level Table 23 - Electromagnetic immunity Power frequency

(50/60Hz) magnetic fields acc. to IEC 61000-4-8 CAUTION Interference may occur in the vicinity of equipment marked with the following symbol:

Page 26 / 27 IFU_EMB_AD_US-CA-EN_V2 12. DISCLAIMER The warranty is valid for twelve months from the date of purchase (unless a more advantageous period has been contractually agreed between the manufacturer and the distributor. Please check with your local distributor for more information). The warranty covers any fault, material damage or manufacturing defect in products used in accordance with the instructions in this leaflet. This warranty does not preclude the application of current legal guarantees under national legislation governing the sale of consumer goods. BIOCORP PRODUCTION is not responsible for:

- Any damage resulting from disregarding the instructions described in this manual.

- Any damage resulting from malfunctioning caused by a combination of connected devices.

- Any damage resulting from transport, improper use or negligence, incorrect handling, modification of the system, poor maintenance, use of incorrect voltage, lightning, infiltration of sand or water, use of parts or accessories not provided or recommended in this manual by BIOCORP PRODUCTION. Page 27 / 27 IFU_EMB_AD_US-CA-EN_V2

Instructions For Use 01-2021 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 TABLE OF CONTENTS P. SYMBOLS IN THESE INSTRUCTIONS FOR USE ................................................................................... 4 STORAGE .................................................................................................................................................. 4 WARNINGS & CAUTIONS ........................................................................................................................ 5 FCC STATEMENTS ................................................................................................................................... 6 0. DIRECTIONS FOR USE .................................................................................................................... 7 FEATURES ............................................................................................................................... 7 INTENDED USE ........................................................................................................................ 7 0.1 0.2 1. MALLYA COMPATIBILITIES WITH PENS ....................................................................................... 8 2. GETTING TO KNOW YOUR MALLYA DEVICE ............................................................................... 9 GETTING STARTED ................................................................................................................. 9 FEATURES OF YOUR MALLYA ............................................................................................. 10 WEIGHT AND SIZE OF THE MAIN ELEMENTS .................................................................... 10 STORAGE INFORMATION ..................................................................................................... 10 TRANSPORT AND PACKAGING ........................................................................................... 11 2.1 2.2 2.3 2.4 2.5 INSTALLING THE MALLYA APPLICATION .................................................................................. 11 TECHNICAL COMPATIBILITIES ............................................................................................ 11 DOWNLOAD THE MALLYA APPLICATION AND GET STARTED ........................................ 12 3.1 3.2 4. CARING FOR YOUR MALLYA ....................................................................................................... 13 CHARGING YOUR MALLYA .................................................................................................. 13 4.1 CALIBRATING YOUR MALLYA .............................................................................................. 14 4.2 ATTACHING YOUR MALLYA TO PEN ................................................................................... 15 4.3 4.3.1 ATTACHING BASE TO PEN ................................................................................................... 15 4.3.2 ATTACHING KNOB TO PEN .................................................................................................. 15 PAIRING YOUR MALLYA ....................................................................................................... 17 4.4 5. USING YOUR INSULIN PEN WITH MALLYA ................................................................................ 19 SECURITY TEST - PRIMING ................................................................................................. 19 INJECTION .............................................................................................................................. 20 5.1 5.2 6.1 6.2 6. MANAGING RECORDED DATA ..................................................................................................... 21 DISPLAY OF THE RECORDED DATA .................................................................................. 21 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 GENERATE A REPORT ......................................................................................................... 24 PAIR TWO MALLYA TO YOUR MOBILE APP. ..................................................................... 25 SETTINGS ............................................................................................................................... 26 HELP SCREEN ..................................................................................................................... 27 7.1 7.2 7.3 7.4 3. IFU_MAL_US_V1.13_January 2021 P a g e 2 | 44 8. TRANSFERRING MALLYA TO A NEW PEN ................................................................................. 28 REMOVING MALLYA FROM THE EMPTY PEN .................................................................... 28 8.1 8.2 TRANSFERRING MALLYA TO A NEW PEN WITH SELECTING THE MOVE MALLYA TO A NEW PEN BUTTON ............................................................................................................................ 28 TRANSFERRING MALLYA TO A NEW PEN WITHOUT SELECTING THE MOVE MALLYA 8.3 TO A NEW PEN BUTTON .................................................................................................................. 30 8.4 INJECTION DATA FROM MALLYA AFTER SMARTPHONE DISCONNECTION ............................................................................................................................... 32 COLLECT YOUR 9. 10. 11. 12. 13. TROUBLESHOOTING ..................................................................................................................... 33 TROUBLESHOOTING MALLYA WITH BASE SIGNALS ....................................................... 33 TROUBLESHOOTING MALLYA WITH THE APPLICATION .................................................. 36 RESET INSTRUCTIONS......................................................................................................... 38 9.1 9.2 9.3 MAINTENANCE AND INSPECTION ...................................................................................... 39 10.1 MALLYA DEVICE LIFETIME ................................................................................................... 39 10.2 MALLYA APPLICATION UPDATES ....................................................................................... 39 10.3 CLEANING YOUR MALLYA ................................................................................................... 39 10.4 MAINTAIN WATER, DUST AND LIGHT RESISTANCE ......................................................... 39 TECHNICAL SPECIFICATIONS ............................................................................................ 40 11.1 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS ................... 40 11.2 MALLYA BASE LABELLING ................................................................................................... 40 SYMBOLS ON THE DEVICE AND ITS PACKAGING ............................................................ 41 11.3 11.4 ELECTRICAL RATINGS ......................................................................................................... 42 11.5 MATERIALS ............................................................................................................................ 42 11.6 ACCURACY ............................................................................................................................ 42 11.7 DISPOSAL ............................................................................................................................... 43 GENERAL INFORMATION .................................................................................................... 44 DISCLAIMER .......................................................................................................................... 44 IFU_MAL_US_V1.13_January 2021 P a g e 3 | 44 SYMBOLS IN THESE INSTRUCTIONS FOR USE Symbol Meaning WARNING CAUTION CAUTION Signification Improper operation may result in serious injury*1 or death to the user, patient Improper operation may result in bodily injury*2 or property damage*3 Disconnect the device from power supply before servicing/cleaning CAUTION Consult the Instructions for Use documents CAUTION Do not use if the packaging is damaged NOTE Important information for operation Table 1 - Symbols used in these IFU (Instructions for Use)

*1 Serious injury means electrical shock or poisoning that causes a subsequent complication or requires hospitalization or long-term outpatient treatment.

*2 Bodily injury means an injury, burn, electrical shock and so on that will not necessitate hospitalization or long-

term outpatient treatment.

*3 Damage to property means extensive damage to a house and/or household goods as well as a domestic animal and pet. STORAGE Store Mallya at room temperature between 59F to 95F (15C to 35C). Keep Mallya away from:

Water Pacemakers and defibrillators Metallic parts Small children. Your Mallya contains small parts that may cause injury or become a choking hazard. IFU_MAL_US_V1.13_January 2021 P a g e 4 | 44 WARNINGS & CAUTIONS NOTES:

- Mallya must only be used for the intended use described in this Instructions for Use document.

- Read the Quick Start Guide and these Instructions for Use before you use Mallya for the first time. Keep these instructions in a safe place.

- Warning and Caution statements are included throughout this document. WARNING: improper operation may result in serious injury or death If you are not certain that you injected your insulin, do not start or repeat your injection. Monitor your blood glucose as instructed by your healthcare provider.

- Disconnect the USB cable from the USB charging port and disconnect Mallya from the USB cable before using it.

- Mallya is not waterproof and holds no protection against the infiltration of water or moisture:

Do not immerse the device in water and do not clean it under running water. Do not expose the device to moisture.

- Avoid using Mallya near PACEMAKERS and DEFIBRILLATORS.

- Mallya contains a magnet, avoid contact with metallic parts during use.

- Do not disassemble, modify or repair the instrument by yourself. Refer all servicing to the BIOCORP PRODUCTION authorized dealer.

- Do not expose the device to temperatures above 40C (104F) or flames.

- Never try to access the internal hardware of your device.

- Small Children: Do not leave your Mallya and its accessories within the reach of small children or allow them to play with it. They could hurt themselves or others or could accidentally damage the device. Your Mallya contains small parts with sharp edges that may cause injuries or that may detach and create a choking hazard.

- Mallya must only be paired with a compatible mobile application.

- Mallya has been designed to work with ONE insulin pen. If you unpair your Mallya base from the insulin pen, you MUST reselect your insulin pen medication.

- Never install a mobile application from unofficial stores on your phone.

- Jailbreak or rooted phone exposes it to dangers and will invalidate the Mallya warranty. CAUTION: improper operation may result in bodily injury or property damage

- The Instructions for Use should be accessible to you at all times and you should consider all instructions carefully before using the device.

- Mallya is intended for Over the Counter use and is not a prescription device.

- Protect your personal health data by using a password on your smartphone (protection with the phone password).

- Do not wipe the surface of Mallya with chemical products or solvents (e.g. acetone) (other than those specified in the cleaning procedure see step 10.3.) as it could lead to discoloration or deterioration. If the device experiences an external mechanical impact (knocking, bumping, dropping, etc.), this may cause malfunctioning of the device. In case of malfunctioning, please contact a BIOCORP PRODUCTION authorized dealer for technical support.

- Mallya is supplied with a USB cable. Do not use any other cable. Use the cable supplied with the device to connect it to a USB power port. Other cables may create problems or interfere with other electronic devices. Before disposing of Mallya: reset the device to delete all your personal health data (see step 9.3.) IFU_MAL_US_V1.13_January 2021 P a g e 5 | 44 STATEMENTS MALLYA Models: 0273694-KWKP, 0273778-FLXP, 0273777-SLST FCC ID: 2AYCW-EZL CAUTION:

- This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

- The user that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

- This device complies with FCC radiation exposure limits set forth for general population. This device must not be co-located or operating in conjunction with any other antenna or transmitter. NOTE:

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on, the user is encouraged to try to correct interference by one or more of the following measures:

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

- Connect the equipment into an outlet on circuit different from that to which the receiver is connected.

- Consult the dealer or an experienced radio/TV technician for help. IFU_MAL_US_V1.13_January 2021 P a g e 6 | 44 0. DIRECTIONS FOR USE 0.1 FEATURES Mallya is composed of a base and a knob that can be mounted on a disposable insulin pen. Mallya knob Mallya base Mallya allows you to:

record the injected selected increment (insulin dose), record the day and time when each insulin dose was injected, transmit the dose, day/time when each insulin dose was injected to a compatible mobile app. on a Bluetooth paired mobile device (smartphone). The compatible mobile application is then able to display the injected Insulin Selected Dose

(ISD) by day/time. 0.2 INTENDED USE Indications for use:

Mallya can be used either for type I or type II diabetes. The device is intended to assist patients maintain accurate records of their insulin usage. WARNING The device should not be used by children and women with gestational diabetes. Contraindications:

There are no known contraindications to the use of Mallya. Intended Patient population:

Intended users are patients and medical professionals. Mallya can only be used by patients already familiar with the pen injectors: Kwikpen (Eli Lilly), Solostar (Sanofi) or Flexpen (Novo Nordisk). Over the Counter (OTC) Medical Device:

Mallya is intended for Over the Counter use and is not a prescription device. Sterility information:

Mallya is intended to be non-sterile. Adverse reaction information:

There are no known adverse reactions to the use of Mallya. Intended use location:

The device is intended for use in a medical office or at home. IFU_MAL_US_V1.13_January 2021 P a g e 7 | 44 1. MALLYA COMPATIBILITIES WITH PENS WARNING Make sure Mallya is compatible with your pen (insulin type and concentration). The molecules and associated concentrations compatible with the Mallya device are listed in the table below:

WARNING EXCLUDED VERSIONS MALLYA IS NOT COMPATIBLE WITH THE FOLLOWING INSULIN PENS:

Humalog Junior MALLYA MODEL INSULINE INN CONCENTRATION Mallya designed for KWIKPEN ELI LILLY insulin pen Mallya designed for FLEXPEN NOVO NORDISK insulin pen Mallya designed for SOLOSTAR SANOFI insulin pen GLARGINE LISPRO LISPRO AND PROTAMINE HUMAN ISOPHANE REGULAR HUMAN USP REGULAR HUMAN AND HUMAN ISOPHANE DETEMIR ASPART ASPART AND PROTAMINE HUMAN ISOPHANE GLARGINE LISPRO GLULISINE GLARGINE AND LIXISENATIDE 100 IU/mL 100 IU/mL 200 IU/mL 100 IU/mL 100 IU/mL 100 IU/mL 100 IU/mL 100 IU/mL 100 IU/mL 100 IU/mL 100 IU/mL 100 IU/mL 300 IU/mL 100 IU/mL 100 IU/mL 100 IU/mL

+33 mcg/mL Table 2 - Mallya compatibilities Molecules and concentrations Toujeo Max Toujeo Doublestar IFU_MAL_US_V1.13_January 2021 P a g e 8 | 44 2. GETTING TO KNOW YOUR MALLYA DEVICE 2.1 GETTING STARTED The shipment box contains the following items. The Part Numbers (PN) vary depending on the Mallya model (Mallya designed for FLEXPEN or KWIKPEN or SOLOSTAR):

Mallya DEVICE:

1 X Mallya BASE For the insulin pen FLEXPEN NOVO NORDISK:

PN: 0273778 For the insulin pen KWIKPEN ELI LILLY:

PN: 0273694 For the insulin pen SOLOSTAR SANOFI:

PN: 0273777 2 X Mallya KNOBS For the insulin pen FLEXPEN NOVO NORDISK:

PN : 0273727 For the insulin pen KWIKPEN ELI LILLY:

PN : 0273698 For the insulin pen SOLOSTAR SANOFI:

PN: 0273710 Applied part Applied part Applied part Applied part 1 x USB CABLE 1 x RESET KEY Mallya ACCESSORIES:

Part Number: B014JOOZFS Model: B004OQOQQ0 Manufacturer:

Bright Sea Industrial. Co Table 3 - Mallya box contents 1 x QUICK START GUIDE Quick Start Guide with reference: QSG_MAL_US CAUTION Consult the Instructions For Use documents:

Reference: IFU_MAL_US NOTE :

Before you use your Mallya for the first time, you have to charge it. Use the provided USB cable to connect the Mallya base to a USB port or outlet. Let it charge for at least 10 minutes. IFU_MAL_US_V1.13_January 2021 P a g e 9 | 44 2.2 FEATURES OF YOUR MALLYA Micro USB port LED Clear square dose window 2.3 WEIGHT AND SIZE OF THE MAIN ELEMENTS Element Weight Size Mallya base 0.016 kg Knob KWIKPEN base:

(60.8x28.9x21.3) mm FLEXPEN and SOLOSTAR bases:

(60.8x26.9x21.3) mm KWIKPEN knob:

SOLOSTAR knob:

(11.6 x 22) mm

(24.4 x 20) mm FLEXPEN knob:

(26.3 x 19.3) mm Mallya knob 0.006 kg Mallya total weight 0.022 kg Table 4 - Weight and size of the main elements 2.4 STORAGE INFORMATION Transport Storage Temperature 10C to +40C

(14F < T < 104F) 10C to +40C

(14F < T < 104F) Operating

+15C to +35C

(59F < T < 95F) Atmospheric pressure Relative humidity 500 hPa to 1060 hPa 10% to 90%

800 hPa to 1060 hPa 10% to 90%

800 hPa to 1060 hPa 30% to 70%

Table 5 - Storage information IFU_MAL_US_V1.13_January 2021 P a g e 10 | 44 2.5 TRANSPORT AND PACKAGING

- The device must be transported and stored in its original packaging. Storage and transport conditions need to meet conditions described in the previous step 2.4.

- Keep the original packaging in case of return or transport of device.

- Check if there is any damage to the packaging. If the packaging is damaged, there is a possibility that the device is also damaged. Please notify the carrier if any damage is found and report it to the manufacturer. CAUTION:

Do not use Mallya if the packaging is damaged.

- Leave the device in a room for 30 minutes before unpacking to ensure there is no condensation. NOTE :

Keep all original packaging for future use. The system must always be transported in its original packaging specially designed to protect it against damage. 3. INSTALLING THE MALLYA APPLICATION Mallya connects your insulin pen to your smartphone!

Use the Mallya smartphone application to keep track of your insulin doses. 3.1 TECHNICAL COMPATIBILITIES The list of smartphones validated by BIOCORP and compatible with the Mallya application Version 1.7. is shown below:

SMARTPHONE MODEL COMPATIBLE OPERATING SYSTEM Android 10.0 Android 9.0 Android 7.0 Android 8.1 Android 8.0 Android 8.0 Android 8.0 iOS13 Samsung Galaxy S9 Samsung Galaxy S8 Plus Samsung Galaxy S6 Honor 10 Huawei P20 Lite Huawei Mate 10 Lite LG V30 iPhone SE iPhone 6s iPhone 6s Plus iPhone 7 iPhone 7 Plus iPhone 8 iPhone 8 Plus iPhone X iPhone XR iPhone 11 CAUTION Table 4 - Mallya application technical compatibilities This list represents the list of smartphones and associated operating systems that have been tested and validated by BIOCORP. This list is not exhaustive. IFU_MAL_US_V1.13_January 2021 P a g e 11 | 44 3.2 DOWNLOAD THE MALLYA APPLICATION AND GET STARTED Download the Mallya application from:

Once installed, select the following icon to open up the application:

The first time you open the application, the Mallya application terms of service screen is displayed. Please read the Mallya application terms of use before accepting them and confirming your choice. before accepting them and confirming your choice. The privacy policy screen is then displayed: make sure you understand it before accessing the Get Started screen. 3.2.1. Select "Get started":

3.2.2. A video will guide you through the unboxing steps. Select "Continue" to watch the Quick Start video:

The next screens will guide you through the 4 operations required to start up your Mallya:

- Switch on (as explained in step 4.1. Charging your Mallya)

- Calibrate (as explained in step 4.2. Calibrating your Mallya)

- Assemble (as explained in step 4.3. Attaching your Mallya to pen)

- Pair (as explained in the following step 4.4. Pairing your Mallya) IFU_MAL_US_V1.13_January 2021 P a g e 12 | 44 CAUTION

- Mallya is supplied with a USB cable. Do not use any other cable. Use the cable supplied with the device to connect it to a USB power port.

- You cannot use your Mallya for an injection while it is connected to a USB power port and 4. CARING FOR YOUR MALLYA 4.1 CHARGING YOUR MALLYA NOTE:

Mallya must be charged before first-time use. charging. 4.1.1. Plug the powered USB cable into the Mallya micro-USB port. 4.1.2. Check that the Mallya LED is slowly flashing green. 4.1.3. Let the battery charge for at least 10 minutes. NOTES:

- Fully recharging the battery takes approximately 2 hours. When the battery is fully charged,

- Optimal autonomy is reached when Mallyas battery is fully charged. You can then use the green LED will turn off. Mallya for at least 2 weeks. IFU_MAL_US_V1.13_January 2021 P a g e 13 | 44 4.2 CALIBRATING YOUR MALLYA 4.2.1. Unplug the Mallya base from the USB cable. 4.2.2. Check that the Mallya LED is flashing orange. 4.2.3. Slowly tilt the Mallya base side to side to CALIBRATE. 4.3.3. Continue tilting until:

The base beeps and the LED light turns green. Then the light will turn off. IFU_MAL_US_V1.13_January 2021 P a g e 14 | 44 4.3 ATTACHING YOUR MALLYA TO PEN CAUTION The Mallya base and knob must be correctly attached onto the pen, otherwise, data will not be transferred. 4.3.1 ATTACHING BASE TO PEN 4.3.1.1. Hold the Mallya base so that the clear square plastic window is facing you 4.3.1.2. Align the Mallya base clear square plastic window with the pen dose window, then snap the base onto the pen. 4.3.1.3. Make sure the Mallya base window the pen dose is aligned with window. NOTE:

A pen symbol is represented on the side of the Mallya base to help you position the pen in the correct orientation. 4.3.2 ATTACHING KNOB TO PEN 4.3.2.1 Place and insert the Mallya knob over your pen injection knob. Make sure the knob is properly attached. 4.3.2.2 The Mallya base LED will flash orange and green when the knob and base are properly mounted onto the pen. IFU_MAL_US_V1.13_January 2021 P a g e 15 | 44 CAUTION The Mallya base LED remains orange if:

the clear square plastic window of the Mallya base and the dose window of the pen are not correctly aligned,

- or, the Mallya knob is not pushed on enough. In this case, it is necessary to:

Re-adjust (re-align) the windows, or, push on the knob,

until the Mallya base LED flashes green and orange. IFU_MAL_US_V1.13_January 2021 P a g e 16 | 44 4.4 PAIRING YOUR MALLYA To pair the Mallya device to the BIOCORP Mallya application, follow the steps indicated below:

4.4.1. Make sure the Mallya base is within 12 inches of your smartphone and select Start pairing:

4.4.2. Select Pair NOTE:

The pairing step may take few seconds. 4.4.3. Choose the insulin pen model onto which the Mallya device is assembled. 4.4.4. Confirm assembled with the Mallya device. pen model the currently NOTE:

In case you cannot find your pen model in the list: select cancel pairing. The application will guide you to pair a new Mallya. NOTE:

If you select No, it does not match, the application will return to the previous screen (step 4.4.3.) to let you choose another pen model. IFU_MAL_US_V1.13_January 2021 P a g e 17 | 44 4.4.5. Well done! Your Mallya device is now paired with your the Mallya application on smartphone. Select OK to move on to the injection screen. 4.4.6. The injection screen is displayed. CAUTION From now on, this Mallya should only be used with this pen model, unless you make a new adjustment. Your insulin pen can now be used as usual and Mallya will track your insulin intake. NOTE:

When Mallya is paired and correctly attached to the injection pen: the LED is green. IFU_MAL_US_V1.13_January 2021 P a g e 18 | 44 5. USING YOUR INSULIN PEN WITH MALLYA NOTE :

Once Mallya is attached to the insulin pen, the pen should be used just like a normal insulin pen. Refer to the manufacturers injector pen Instructions for Use. 5.1 SECURITY TEST - PRIMING WARNING Always perform a priming (safety test) before each injection to ensure that:

Your pen and the needle are working properly, The right dose of insulin will be injected. If you do NOT perform the priming, you may receive too much or too little insulin (refer to the manufacturers injector pen Instructions for Use). 5.1.1. Follow the injectable insulin pen Instructions for Use to carry out the priming step. 5.1.2. At the end of the priming step, keep the injection knob pressed down:

- While Mallyas green LED is flashing,

- Until Mallya emits an audible signal (BEEP) signaling the end of the priming step. WARNING If the liquid does not come out of the needle tip during the safety test, do not use the pen and refer to the manufacturers injector pen Instructions for Use for more information to solve the problem. 5.1.3. You can release the pressure on the knob when the green LED stops flashing and the BEEP signaling the end of priming is emitted. The Mallya application will automatically detect a priming if:

You are priming 1 or 2 unit(s), and You perform your insulin injection just after the priming step (within 2 minutes) CAUTION If the time interval between the two consecutive injections exceeds 2 minutes, the application will automatically detect an injection instead of a priming. NOTE :

You can always change an injection recorded as a dose to a priming, or a priming to a dose in case it has not been suitably categorized. Please refer to step 6.2.2. IFU_MAL_US_V1.13_January 2021 P a g e 19 | 44 5.2 INJECTION WARNING If you are not certain that you injected your insulin, do not start or repeat your injection. Monitor your blood glucose as instructed by your healthcare provider. 5.2.1. Check the insulin dose to inject as requested by the drug manufacturers requirements. 5.2.2. Turn the dose knob to select the number of units to inject. The dose indicator should line up with the dose to inject. 5.2.3. Press on the injection knob with your thumb until you return to ZERO (complete dose injection) 5.2.4. Keep the injection knob pressed in and the needle in the skin:

- While the Mallyas green LED is flashing,

- Until Mallya emits an audible signal (BEEP) signaling the end of the injection. 5.2.5. You can release the pressure on the knob and then remove the needle from the skin when the green LED stops flashing and the BEEP signaling the end of injection is emitted. WARNING If you do not see ZERO (0) in the pen dose window: it indicates that the full dose has not been injected. The Mallya application will automatically detect an injection:

The information corresponding to the injected dose is displayed: dose, day and time. IFU_MAL_US_V1.13_January 2021 P a g e 20 | 44 6. MANAGING RECORDED DATA Once data is transferred from a paired compatible Mallya, you can display and manage any recorded data using the Mallya application as follows:

6.1 DISPLAY OF THE RECORDED DATA Select the injection screen:

Doses or Priming injections are then displayed as follows:

DOSES PRIMING The Insulin Dose information is displayed:

Type of injection: priming or dose Injection day and time Insulin dialed dose (in International Unit) Color indicator of the injected insulin type or concentration IFU_MAL_US_V1.13_January 2021 P a g e 21 | 44 6.2 MANAGE YOUR RECORDED DATA You can manage and edit the following list of items:

- You can change a priming or a dose quantity (see step 6.2.1.),

- You can change an injection recorded as a dose to a priming, or a priming to a dose

(see step 6.2.2.),

- You can delete a dose or a priming (see step 6.2.3.),

- You can add an injection that was not recorded to the history (see step 6.2.4.),

- You can fill in a dose that was not captured by the device (see step 6.2.5.). 6.2.1 You can change a priming or a dose quantity already recorded 6.2.2 You can change an injection recorded as a dose to a priming, or a priming to a dose IFU_MAL_US_V1.13_January 2021 P a g e 22 | 44 6.2.3 You can delete a dose or a priming 6.2.4 You can add an injection that was not recorded to the history To add an unrecorded dose, select Add to log:

IFU_MAL_US_V1.13_January 2021 P a g e 23 | 44 6.2.5 You can fill in a dose that was not captured by the device If a dose was not captured, you will see the message Dose not recorded. You can add the dose information as follows:

Tap to modify the information related to the injection:

7. OTHER FEATURES OF THE MALLYA APPLICATION 7.1 GENERATE A REPORT In the Injections screen, select the icon generate a report:

to display the window that allows you to Injections screen IFU_MAL_US_V1.13_January 2021 P a g e 24 | 44 7.2 PAIR TWO MALLYA TO YOUR MOBILE APP. Mallya Devices screen Both Mallya devices and associated insulin pens can be used independently. They both have the status Ready for use:

WARNING Make sure you do not switch the pens between the two Mallya devices. In case you have any doubt, you can use the Find the device functionality to identify the Mallya as explained in the step below (step 7.3.) IFU_MAL_US_V1.13_January 2021 P a g e 25 | 44 7.3 SETTINGS Select

, then Settings to diplay the screens allowing to set up the application:

Mallya Devices screen Battery status :

When Mallya is fully charged (after approximately 2 hours) : 4 bars are displayed Device status: Mallya is connected / Disconnected since CAUTION A Bluetooth connection is necessary to transmit the injection data. Tap Insulin to select the pen model onto which Mallya is currently assembled. Each color indicator is associated to a type of insulin pen:

Apidra CAUTION It is important to check, before each injection, that the type of insulin selected in the application corresponds to the type of insulin indicated on the label of your pen. The color indicators are also displayed in the injections screen so that you can differentiate between the types of insulin injected in the injection log. Example:

Sound signals: you can activate / deactivate the silent mode. IFU_MAL_US_V1.13_January 2021 P a g e 26 | 44 Find the device: select this option to make the Mallya ring* in order to identify or locate the device.

*Only if the Mallya is in STANDBY mode. About Information about Mallya application:

- Manufacturer

- Model

- Serial number

- Hardware revision

- Firmware revision

- Software revision

- Temperature Forget the device Select Forget Mallya to unpair Mallya.

CAUTION If you unpair your Mallya while it is out of range, you will have to reset the system before pairing your Mallya again, in accordance with the procedures described in the step 9.3. - Reset Instructions.

- Mallya has been designed to work with ONE insulin pen. If you unpair your Mallya base from the insulin pen, you MUST reselect your insulin pen medication. 7.4 HELP SCREEN Video tutorials and other resources are available from the "Help" screen:

The legal notices concerning the Terms of use, the Privacy, Copyright and Version of the application (About) are also available. Help screen IFU_MAL_US_V1.13_January 2021 P a g e 27 | 44 8. TRANSFERRING MALLYA TO A NEW PEN 8.1 REMOVING MALLYA FROM THE EMPTY PEN Follow the procedure indicated below when your insulin pen is empty:

8.1.1. Remove the Mallya base from the insulin pen. Use your thumb to press on Mallya and to remove it from the pen. 8.1.2. Then, remove the Mallya knob knob from the pen. 8.2 TRANSFERRING MALLYA TO A NEW PEN WITH SELECTING THE MOVE MALLYA TO A NEW PEN BUTTON When your pen is out of insulin and you want to switch to a new pen, follow the steps below:

8.2.1. Select the screen or devices screen. button on the log 8.2.2. Follow the app instructions or the steps indicated below to:

Remove the Mallya base and Mallya knob from the current pen (see step 8.1. Removing Mallya from the empty pen) Assemble the Mallya base and Mallya knob to the new insulin pen (see step 4.3. Attaching your Mallya to pen): the Mallya should show a green light. If not, check the position of the Mallya knob and Mallya base. Log screen or device screen CAUTION

- Mallya models are only compatible with the disposable insulin pens (Solostar, Kwikpen, Flexpen) they are designed for. Do not attach to, pair or use with any other insulin pen types. If you need to inject more than the number of units left in the pen, you may either:

1) inject the amount left in your pen and then use a new pen to deliver the rest of your dose:

the Mallya application will then display 2 successive injections, or 2) get a new pen and inject the full dose: the Mallya application will display one full dose injection. IFU_MAL_US_V1.13_January 2021 P a g e 28 | 44 NOTE :

It is not necessary to pair your Mallya again when changing the pen (unless your system has been reset - see step 9.3. Reset instructions). 8.2.3. Moving Mallya to the same pen model or to a different pen model 8.2.3.1 Moving mallya to the same pen model If you choose to move MALLYA to the same pen model, select:

The same pen model, currently assembled, is then displayed at the top of the screen. (LANTUS in the example) 8.2.3.2 Moving mallya to a different pen model If you choose to move MALLYA to a different pen model, select:

On the next injection, the injection dose will be displayed in the injection history as if no Mallya transfer had taken place. The new pen model, currently assembled, is then displayed at the top of the screen. (APIDRA in the example) In this case, the screens in steps 4.4.3., 4.4.4., and 4.4.5. are displayed. You have to select the new pen model on which your Mallya is currently assembled. On the next injection, the injection dose will be displayed in the injection history with the new model of pen (APIDRA in the example above) IFU_MAL_US_V1.13_January 2021 P a g e 29 | 44 8.3 TRANSFERRING MALLYA TO A NEW PEN WITHOUT SELECTING THE MOVE MALLYA TO A NEW PEN BUTTON CAUTION When Mallya is transferred onto a new pen without selecting the button, the application automatically detects a device removal event (eg.: your base and /

or the knob have / has been removed from the original pen). In this situation, the application will require a confirmation of the pen currently assembled with Mallya. EXAMPLE:

8.3.1. Log screen before transferring Mallya onto a new pen:

8.3.2. Remove Mallya from the empty pen / attach Mallya onto a new pen (base and / or knob) 8.3.3. On the next PRIMING or an INJECTION:

A DEVICE REMOVAL EVENT IS DETECTED!

IFU_MAL_US_V1.13_January 2021 P a g e 30 | 44 The following screen is displayed with 2 options to choose from:

YES, this device is exclusively used with the same type of pen (same as the original pen). In this case, the injection dose will be displayed in the injection history as if no removal event had taken place. Example with the LANTUS pen model

(Pen unchanged) NO, I have placed this device on another type of pen. 1) In this case, the screens in steps 4.4.3., 4.4.4., and 4.4.5. are displayed. You have to select the new pen model on which your Mallya is currently assembled. The new pen model currently assembled is then displayed at the top of the screen

(Apidra in the example below):

Example with a new pen model selected

(APIDRA pen model currently assembled to Mallya) 2) Following your change of pen model, some new injections (or primings) are pending confirmation of the insulin type that has been used. Those injections are displayed in the list above with a grey colored circle and the insulin undetermined text:

Select this icon to choose the pen model used during the injection. Example of display with the pen model

"APIDRA" selected:

IFU_MAL_US_V1.13_January 2021 P a g e 31 | 44 Example with the pen model

"APIDRA"

selected (used for the injection) 8.4 COLLECT YOUR INJECTION DATA FROM MALLYA AFTER SMARTPHONE DISCONNECTION Your smartphone may disconnect from the Mallya system if Bluetooth is out of range, or the battery is empty, or for other potential reasons. In this case, you can still use Mallya to record your insulin doses and, on the next connection, data will be automatically transferred from Mallya to your smartphone. Upon re-connection, 2 options are possible:

- Your Mallya application will display the recorded injections data as usual if no removal event occurred during the disconnection period (eg.: your base and / or the knob have / has not been removed from the original pen in the meantime), or

- Your Mallya application will display the 2 options indicated in step 8.3.3. if a removal event occurred (the Mallya base and / or the knob have / has been removed from the original pen during the disconnection period). Follow the instructions in step 8.3.3. to indicate:

the pen model on which your Mallya is currently assembled, and the pen model used for the injections (or primings) during the disconnection period. CAUTION Upon a first injection following a disassembly, make sure you reconnect the device with the application as soon as possible to avoid Insulin undetermined doses. IFU_MAL_US_V1.13_January 2021 P a g e 32 | 44 9. TROUBLESHOOTING CAUTION circumstances.

- Never attempt to access the internal hardware for any purpose including maintenance in all

- When a function check is not successful and if the recommendations given in this step 9. do not solve the issue, you are prompted to contact a BIOCORP PRODUCTION authorized dealer. 9.1 TROUBLESHOOTING MALLYA WITH BASE SIGNALS When a visual or audible signal occurs on your Mallya, check the cause and follow the indications listed below to solve the issue:

CAUSE TROUBLESHOOTING STEPS SIGNAL Red LED Mallya error Remove Mallya from pen. Re-calibrate Mallya (see step 4.2.) If the issue persists: reset the system

(see step 9.3.) Then, try to pair Mallya to your smartphone (see step 4.4.) If the problem is not solved, please contact a BIOCORP PRODUCTION authorized dealer. Slowly tilt the Mallya side to side to calibrate (see step 4.2.) Orange LED (rapid flashing) Alternating orange and green flashing (rapid flashing) Calibration in progress: A green light will appear for 2 seconds upon successful calibration (with a beep, then the green light will turn off). Orange LED (slow flashing)

(every 15 seconds) Orange LED Mallya device is correctly positioned onto the pen but must be paired. Pair Mallya to your smartphone (see step 4.4.) Battery is low. Plug in and charge the Mallya base (see step 4.1.)

- Mallya position error on pen:

the knob is not turned back to the dose 0 or

- Assembling error:

Mallya (base or knob) is not correctly positioned on pen. or

Make sure that:

the knob is turned back to the dose 0 the Mallya window and the pen dose window are properly aligned, and the Mallya knob is correctly pushed onto the pen Table 7 - Troubleshooting with signals

(see step 4.3.) IFU_MAL_US_V1.13_January 2021 P a g e 33 | 44 CAUTION ORANGE LED TROUBLESHOOTING RECOMMENDATIONS The Mallya base light indicator (LED) remains orange if:

a) The clear square plastic window of the Mallya base and the dose window of the pen are not correctly aligned, or b) The Mallya base is mounted too high / too low on the pen, c) Or, if the Mallya knob is not pushed on enough. In this case, it is necessary to:

a) Check that the Mallya window outline lines up with the pen dose window EXACTLY:

-The pen pointer should fit into the slot on the Mallya base.

-The notch in the pen dose window should line up with the notch on the Mallya window outline. b) Check that the top edge of the Mallya base lines up with the edge of the pen body, so that it does not sit below or above the edge. The Mallya base should not cover any of the pen dose dial. c) Press the Mallya knob onto the pen dose dial so that it almost touches the Mallya base. When the positions of the Mallya knob and button are correct:

- the Mallya base LED flashes green and orange if Mallya is not paired,

- the Mallya base LED is green if Mallya is paired. IFU_MAL_US_V1.13_January 2021 P a g e 34 | 44 INFORMATIONS REGARDING OTHER SIGNALS:

CAUSE SIGNAL Green LED (slow flashing) TROUBLESHOOTING STEPS Mallya is charging.

(See step 4.1.) Green LED Green LED (rapid flashing) Mallya is properly assembled onto the pen. It is:

- either ready for use, or the dose setting is in

progress, or the injection is in progress

N/A Mallya is at the end of an injection. Table 7 - Troubleshooting with signals (next) Keep the needle in the skin:

- During the whole time Mallyas green LED is flashing,

- Until Mallya emits an audible signal (BEEP) signaling the end of the injection. IFU_MAL_US_V1.13_January 2021 P a g e 35 | 44 9.2 TROUBLESHOOTING MALLYA WITH THE APPLICATION This step describes the troubleshooting procedures you can perform if there is a problem with your Mallya. Find the problem you are experiencing among those listed in the following list and apply the appropriate solution.

If the recommended solutions do not eliminate the problem or if you encounter an unlisted problem, please contact a BIOCORP PRODUCTION authorized dealer. INDICATION CAUSE TROUBLESHOOTING STEPS Mallyas base not detected Select: Not Ready Check that the Mallya device is correctly assembled on the pen (see step 4.3.) Knob of the pen not at ZERO Select: Not Ready Turn the knob of the pen back to the ZERO position. Table 8 - Troubleshooting with app. IFU_MAL_US_V1.13_January 2021 P a g e 36 | 44 INDICATION CAUSE TROUBLESHOOTING STEPS Calibration error Select Error Perform the calibration as indicated in the Mallya device Instructions for Use (see step 4.2.) Mallya is maybe too far away from your smartphone and therefore disconnected Or Move your Mallya device and your smartphone closer to one another. A communication error occurred Select Disconnected Reset Mallya as explained in the Mallya device Instructions for Use (see step 9.3.) Bluetooth issue or signal lost Check that the Mallya device is powered ON. Check that the Mallya device is connected to the App. Check the Bluetooth connection status on your mobile phone. If the problem is not solved, please contact a BIOCORP PRODUCTION authorized dealer. Table 8 - Troubleshooting with app. (next) IFU_MAL_US_V1.13_January 2021 P a g e 37 | 44 9.3 RESET INSTRUCTIONS The reset procedure of Mallya may be necessary:

PROCEDURE:

If Mallya is not working properly (no response, etc), If you need to pair Mallya with another mobile phone (smartphone), If you want to delete your personal health data from the device. 9.3.1. Disassemble Mallya as indicated step 8.1. 9.3.2. Flip Mallya over so that you can see the following indications:

9.3.3. Take the Reset Key:

9.3.4. Insert the Reset Key into the hole shown below and WAIT until 3 beeps are emitted before removing the key. 3 BEEPS 9.3.5. Then follow step 4. to prepare your device for a new operation. IFU_MAL_US_V1.13_January 2021 P a g e 38 | 44 10. MAINTENANCE AND INSPECTION 10.1 MALLYA DEVICE LIFETIME Mallya and accessories lifetime is 2 YEARS. 10.2 MALLYA APPLICATION UPDATES Check each week on your smartphone (in the Apple store / Play store) if a Mallya application update is available, and update when available. 10.3 CLEANING YOUR MALLYA When the surface of Mallya is dirty, follow the steps indicated below to clean it:

Disconnect the USB cable from Mallya. Wipe the surface of the device with a slightly damp lint-free cloth. You can wipe off persistent dirt with a soft lint-free cloth slightly moistened with soapy water. Dry with a clean, dry cloth.

- Disconnect the USB cable before cleaning Mallya. WARNING The device is intended to be non-sterile CAUTION

- Avoid getting moisture into the micro-USB opening.

- Do not wipe the surface of Mallya with chemical products or solvents (e.g. acetone) (other than those specified in this cleaning procedure) as it could lead to discoloration or deterioration.

- Remember that Mallya is not waterproof:

Do not immerse the device in water and do not clean it under running water. Do not expose the device to moisture. Do not use the device in the bathroom or in areas with high temperature, humidity, dust or rain.

- Do not share Mallya with other people to prevent infection. 10.4 MAINTAIN WATER, DUST AND LIGHT RESISTANCE As defined in the IEC standard 60529, the IP code (or Ingress Protection code) classifies and rates the degree of protection provided by mechanical casing and electrical enclosure against the intrusion of solid objects, dust, accidental contact, and water. Mallya is rated IP22 using this Ingress Protection rating system: your device has shown to be water and dust resistant in certain circumstances Despite this classification, your device is not at all impermeable to water damage. NOTE:

If any liquid is found to have entered your device components (inside the sealed system): your devices warranty will be void. Follow the next tips carefully to prevent damage to the device (operational or cosmetic issues):

- Whenever your device gets wet, dry it thoroughly with a soft, dry and clean cloth. You should dry the inside of the charging port before inserting a power connector to charge your device. If the charging port is not fully dry, your device may operate abnormally. For example, it may charge more slowly or overheat.

- Do not expose the device to direct sunlight. IFU_MAL_US_V1.13_January 2021 P a g e 39 | 44

If the device is dropped or receives an impact, its water and dust resistance may be impaired. 11. TECHNICAL SPECIFICATIONS 11.1 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS COMPLIANT STANDARDS DESCRIPTION CLASSIFICATION Protection type against electric shock Degree of protection against electric Class II (double isolation) Type BF IEC 60601-1 shock Mode of operation Continuous operation to EN 55011 the device

According CISPR 11 is classified as a group 1 device with class B emission limits. IEC 60601-1-2 Electromagnetic compatibility IEC 60529 IP22 for the base Type of protection against the access to hazardous parts and the infiltration of water as detailed in the current edition of IEC Table 9 - Compliance with standards / regulations and classifications 11.2 MALLYA BASE LABELLING MALLYA SENSOR TYPE LABELING Mallya base for insulin pen:

FLEXPEN NOVO NORDISK Mallya base for insulin pen:

KWIKPEN ELI LILLY Mallya base for insulin pen:

SOLOSTAR SANOFI Table 10 - Base labelling IFU_MAL_US_V1.13_January 2021 P a g e 40 | 44 11.3 SYMBOLS ON THE DEVICE AND ITS PACKAGING SYMBOL STANDARDS DESCRIPTION IEC60417-5840 Applied part Type BF ISO7010-M002 Please refer to the Instructions for Use document ISO 15223-1 Consult the Instructions for Use documents ISO 15223-1 Do not use if the packaging is damaged ISO 15223-1 Manufacturer ISO 15223-1 Manufacturing date Symbol 5.3.4 (ISO 7000-

0626) of ISO 15223-

1:2012 Moisture sensitive device The device, packing and accessories must be disposed of separately from domestic waste in accordance with WEEE provisions for EU member countries, and with local recycling provisions and national laws. ISO 15223-1 Serial Number Product reference This device complies with part 15 of the FCC Rules. Operation is subject to the following 2 conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. IEC 60417-5172 Class II device

(in compliance with EN 60601-1 standards) IEC 60417-5957 For indoor use only IP 22 IEC 60529 Protection index: Protects persons against access to hazardous parts with fingers and against the harmful effects due to water vertically dripping against the enclosure. Symbol 5.3.7 (ISO 7000-

0632) of ISO 15223-

1:2012 Symbol 5.3.8 (ISO 7000-

2620) of ISO 15223-

1:2012 Temperature limits within which the device can be safely exposed Humidity limits within which the device can be safely exposed Table 11 - Symbols on the device and its packaging IFU_MAL_US_V1.13_January 2021 P a g e 41 | 44 SYMBOL STANDARDS Symbol 5.3.9 (ISO 7000-

2621) of ISO 15223-

1:2012 DESCRIPTION Pressure limits within which the device can be safely exposed Table 12 - Symbols on the device and its packaging (next) 11.4 ELECTRICAL RATINGS Make sure you connect the Mallya USB cable to a power source compliant with the IEC 60601-

1. USB CHARACTERISTICS 5V DC 2A 500mA IP 22 BATTERY CHARACTERISTICS Model Number Operating time with fully charged battery Charging time for fully charged battery Li-ion rechargeable :

Li-ion 3,7V-130mAh GEB401730 / FT401235P 2 weeks Full charge at 4,2 V for 2,5 hours Table 13 - Electrical ratings It is possible to connect the provided USB cable to the USB port of your PC or AC adaptor with the following characteristics:

AC ADAPTOR (NOT PROVIDED) External Module with automatic adaptation of the voltage: no selection is required. 90-264 Vac 47-63 Hz 0,5 A @ 90 VA CAUTION Input voltage Min Voltage Ingress Protection Battery Power supply Input voltage range Frequency range Current input Category 11.5 MATERIALS Mallya base Mallya knob 11.6 ACCURACY II (double insulation) Table 13 Electrical ratings (next) MATERIALS PC/ABS (cover) Copolyester (body) Polypropylene (body) POM (knob) Table 14 - Materials MEASUREMENT ACCURACY 99%

Table 15 Accuracy IFU_MAL_US_V1.13_January 2021 P a g e 42 | 44 CAUTION External factors may affect the dose measurement accuracy. Factors Affect the measurement Ambient Temperature Magnetic disturbance Dose Knob position Table 16 - External factors and measurement accuracy Does not affect the measurement To display accurate doses, make sure to use the device as recommended in this Instructions for Use document:

- Follow the Warning and Caution recommendations to avoid magnetic disturbance

- Follow the information given step 4.3.2. to adjust the dose knob position on the pen 11.7 DISPOSAL Dispose of Mallya according to your local guidelines. According to Directives 2012/19/UE WEEE and 2011/65/UE RoHS II on the restriction of hazardous substances in electrical and electronic equipment on their disposal:

Public authorities adopt adequate measures to make sure that users, distributors and manufacturers contribute to the collection of electrical and electronic equipment, setting legal requirements to reuse, recover or recycle the said equipment. CAUTION You must take into account the potentially harmful effects to the environment or human health due to the improper disposal of the equipment or of parts of it. The following graphic symbol is applied on the label of the equipment:

It reminds that all electrical and electronic equipment must be collected and disposed of separately from domestic waste at the end of life. CAUTION Before disposing of Mallya: reset the device to delete all your personal health data (see step 9.3.) IFU_MAL_US_V1.13_January 2021 P a g e 43 | 44 12. GENERAL INFORMATION BIOCORP PRODUCTION ZI LAVAUR LA BECHADE 63500 ISSOIRE CEDEX FRANCE Tel : +33 4 73 55 70 50 www.biocorpsys.com DISTRIBUTORS

(authorized dealers):

See list and contact information at the end of leaflet The Instructions for Use must be accessible to you at all times. You must read all instructions carefully before using the device. If you have technical problems with our product, please contact a BIOCORP PRODUCTION authorized dealer. The following information will be needed in order to provide you with the necessary assistance:

Serial Number of your Mallya unit (this SN number can be found on the device label) 13. DISCLAIMER The warranty is valid twelve months from the date of purchase. The warranty covers any fault, material damage or manufacturing defect in products used in accordance with the instructions in this leaflet. This warranty does not preclude the application of current legal guarantees under national legislation governing the sale of consumer goods. BIOCORP PRODUCTION is not responsible for:

- Any damage resulting from disregarding the recommendations described in this Instructions for Use document.

- Any damage resulting from malfunctioning caused by a combination of connected devices.

- Any damage resulting from transport, improper use or negligence, incorrect handling, modification of the system, poor maintenance, use of incorrect voltage, lightning, infiltration of sand or water, use of parts or accessories not provided or recommended in this Instructions for Use by BIOCORP PRODUCTION. Healthcare data protection The terms of the regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 may apply to the interactions between Biocorp Production and users of its products. To this end, Biocorp Production agrees to comply with its obligations in accordance with the regulation applicable to Personal data protection and makes every effort to guarantee the security, confidentiality, and integrity of the Personal data that it may process. A user has the right to access their data, rectify them, request their deletion, or exercise their right to limit the processing of such data. They may withdraw their consent to the processing of such data at any time; they may also object to the processing of their data and exercise their right to the portability of such data. To exercise these rights, please contact: gdpr@biocorp.fr If a user considers, after having contacted Biocorp Production, that their Data Protection and Privacy rights have not been respected or that the access control provision does not comply with data protection rules, such user may file a claim online or by mail with the relevant national data protection authority. IFU_MAL_US_V1.13_January 2021 P a g e 44 | 44

LCIE SUD EST Laboratoire de Moirans Z.I. CentrAlp 170, Rue de Chatagnon 38430 MOIRANS - FRANCE FCCID:

2AYCW-EZL PRODUCT LABELING Page 1/1

Letter of Agency To:

Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046-1609 Curtis-Straus LLC TCB One Distribution Center Circle #1 Littleton, MA 01460 February 5, 2021 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

CONFIDENTIALITY REQUEST Bureau Veritas Consumer Products Services Inc. One Distribution Center Circle #1 Littleton, MA 01460 USA March 31, 2021 Re:

FCC ID:

Confidentiality request 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 2. Block Diagram description of the equipment 3. Operational description of the equipment 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:

Signature:

(file: Schematic - 2AYCW-EZL.pdf)

(file: Block Diagram - 2AYCW-EZL.pdf)

(file: Operational Description - 2AYCW-EZL.pdf) VP QUALITY & REGULATORY AFFAIRS

ODI|d Na BIOCORP variation declaration concerning the differences between:

MALLYA / EMBODY models BIOCORP PRODUCTION Z| de Lavaur La Bechade 63500 ISSOIRE, France A company duly registered and organized under the laws of France, guarantee and declare, under our sole responsibility, that the device:

Device trademark: MALLYA / EMBODY is declined into several models. Each model has been specifically designed to adapt an insulin pens platform available on the market:

Models Device designed for ; ;

9 f designation Models reference Picture MALLYA DESIGNED FOR MALLYA for A442) hee Mash eee MALLYA DESIGNED FOR a ecole FLEXPEN NOVO NORDISK FLEXPEN a eel MALLYA DESIGNED FOR NER Sole SOLOSTAR SANOFI SOLOSTAR areata ie EMBODY DESIGNED FOR EMBODY* for SOLOSTAR SANOFI SOLOSTAR ae tedie

*Only the device trademark is different between MALLYA and EMBODY for SOLOSTAR. The name EMBODY has spe LY-t-ag meg telk 0 BOM E Cele Ld OL The MALLYA / EMBODY variants are almost similar:

Seats MarR agtT LUM L oleh

- they have the same hardware. They include the same electronic board and battery (in the base):

The MALLYA / EMBODY models have:

the same schematic diagram, PCB layout and RF spec.

- they are made of materials from the same identified list Overall, the difference between each model is only slight dimensional:

oie os Pcs en Daa) Pears DEL es OTL e ahs ay SO1OSTAR KWIKPEN MaBya button ote y ye) amo SOLOSTAR Mallya total So tliis

- The MALLYA/ EMBODY base window is different between each MALLYA/ EMBODY model to specifically adapt to the specific injector pen dose window.

- The MALLYA/ EMBODY button shape vary to specifically adapt to the pen injection button it is affixed on. Issoire, January 29, 2021 NE Tio VE ROrViIIA|

Aiden Ulla mir lem as iNeed et BIOCORP PRODUCTION - ZI Lavaur La Bchade 63500 Issoire France TEL : +33 (0)4 73 55 70 50 FAX : +33 (0)4 73 55 01 86 WEBSITE:

Limited company with a board of directors with a share social capital of 207 349,40 registered with the Clermont-Ferrand RCS 453 541 054 BUSINESS ID NUMBER 453 541 054 00012 VAT intra-community : FR 03 453 541 054 www.biocorpsys.com ww (028 % F eZ) POUR 1 Raa: 14)

<4 BD) RAE AC) ww iC L2X 8Z*9'09)