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BIOCORP Mallya Instructions For Use Manual

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10-2020
Instructions For Use
®
®
®
®
Designed for Flexpen
Novo
Designed for Kwikpen
Eli Lilly
Designed for Solostar
Sanofi
Nordisk
Embedded software version 3.7.
Helping you keep track of your insulin doses
IFU_MAL_EN_V6

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  • Page 1 10-2020 Instructions For Use ® ® ® ® Designed for Flexpen Novo Designed for Kwikpen Eli Lilly Designed for Solostar Sanofi Nordisk Embedded software version 3.7. Helping you keep track of your insulin doses IFU_MAL_EN_V6...

  • Page 2: Table Of Contents

    COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS ....7 MALLYA BASE LABELING .....................7 TRANSPORT AND STORAGE CONDITIONS ...............8 USAGE CONDITIONS ......................8 DISPOSAL ..........................8 UNPACKING AND INSTALLING MALLYA (CHARGING / CALIBRATING / ASSEMBLING / PAIRING) ..............................9 UNPACKING YOUR MALLYA AND ITS ACCESSORIES ............9 5.1.1 PACKAGE CONTENTS ......................9 5.1.2...
  • Page 3 MALLYA AFTER SMARTPHONE DISCONNECTION ..........................29 TROUBLESHOOTING ......................... 30 TROUBLESHOOTING MALLYA WITH VISUAL AND AUDITIVE BASE SIGNALS .... 30 TROUBLESHOOTING MALLYA WITH THE APPLICATION ..........32 RESET INSTRUCTIONS ..................... 34 MAINTENANCE AND INSPECTION ................... 34 10.1 MALLYA DEVICE LIFETIME ....................34 10.2...
  • Page 4 SYMBOLS USED IN THIS MANUAL Symbol Meaning Explanation Improper operation may result in serious WARNING injury* or death to the user, patient Improper operation may result in bodily injury* CAUTION or property damage* Disconnect the device from power supply CAUTION before servicing/cleaning NOTE Important information for operation...
  • Page 5 Device features Mallya is composed of a base and a button that can be mounted on a disposable insulin pen. Mallya button 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.

  • Page 6: General Information

    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) MALLYA COMPATIBILITIES – MOLECULES AND CONCENTRATIONS WARNING Make sure Mallya is compatible with your pen (insulin type and concentration).

  • Page 7: Device Description And Exam Environment

    ESSENTIAL PERFORMANCES OF THE SYSTEM (SIGNIFICANT OPERATING CHARACTERISTICS) The essential performance for the Mallya 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 patient’s smartphone:...

  • Page 8: Weight And Size Of The Main Elements

    USB CABLE RESET KEY PN: 0373707 PN: 0373708 Table 5 - Parts necessary for operation NOTE: To upload the Mallya application, please refer to section 5.4.1. Installing the “Mallya” application. WEIGHT AND SIZE OF THE MAIN ELEMENTS ELEMENT WEIGHT INSULIN PEN...

  • Page 9: Warnings And Cautions

    NOTES: - Mallya must only be used for the intended use described in this manual. - Read these instructions before you use Mallya 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 40°C (104°F) or flames).

  • Page 10: Electrical Safety

    ELECTRICAL SAFETY 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.

  • Page 11: Compliance With Standards / Regulation And Classifications

    ELI LILLY insulin Mallya designed for SOLOSTAR ® SANOFI insulin Table 10 - Mallya 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 7 / 41...

  • Page 12: Transport And Storage Conditions

    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 section 9.3.) Page 8 / 41...

  • Page 13: Unpacking And Installing Mallya

    UNPACKING INSTALLING MALLYA (CHARGING CALIBRATING / ASSEMBLING / PAIRING) CAUTION - Mallya can only be paired with a compatible mobile application. - Mallya is only compatible with the insulin pens:  Flexpen ® Novo Nordisk  Kwikpen Eli Lilly (except for ®...

  • Page 14: Charging And Calibrating Your Mallya

    Mallya must be charged before first-time use. 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. Never use your Mallya for an injection while it is connected to a USB power port and charging.

  • Page 15: 5.2.2 Calibrating Your Mallya

    If the orange LED does not light up after disconnecting the USB cable from the Mallya base, it means that the calibration was done automatically. You can go directly to the next section: Section 5.3. Assembling your Mallya to the insulin pen.

  • Page 16: Assembling Your Mallya To The Insulin Pen

    ASSEMBLING YOUR MALLYA TO THE INSULIN PEN CAUTION The Mallya base and button must be correctly attached onto the pen, otherwise, data will not be transferred. 5.3.1 ATTACHING BASE TO PEN Hold the Mallya base so that clear square plastic window is facing...

  • Page 17: Pairing Mallya With Your Smartphone

    Use the Mallya smartphone application to keep track of your insulin doses. Technical compatibilities The list of smartphones validated by BIOCORP and compatible with your Mallya application version for iOS or Android is available from your local representative or from the BIOCORP manufacturer. Download the Mallya application and get started...
  • Page 18 "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 section 5.2.1. Charging your Mallya) - Calibrate (as explained in section 5.2.2. Calibrating your Mallya) - Assemble (as explained in section 5.3.
  • Page 19 5.4.2 PAIRING To pair the Mallya device to the BIOCORP Mallya application, follow the steps indicated below: Make sure the Mallya base is within Select “Pair” 30 cm of your smartphone and NOTE: select “Start pairing”: The pairing step may take few seconds.
  • Page 20 Your insulin pen can now be used as usual and Mallya will track your insulin intake. When Mallya is paired to the compatible mobile application and correctly attached to the insulin pen: the Mallya LED is green.

  • Page 21: Operating Instructions

    OPERATING INSTRUCTIONS NOTE: Once Mallya is attached to the insulin pen, the pen should be used just like a normal insulin pen. Refer to the manufacturer’s injector pen user manual. SECURITY TEST - PRIMING WARNING Always perform a priming (safety test) before each injection to ensure that: ...

  • Page 22: Injection

    If you do not see ZERO (“0”) in the pen dose window: it indicates that the full dose has not been injected. If the above instructions are followed, the Mallya application will automatically detect an injection: The information corresponding to the injected dose is displayed: Injected dose, day and time.

  • Page 23: Manage Recorded Data

    MANAGE 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: DISPLAY OF THE RECORDED DATA Select the “injections” icon of the application to display information related to the history of injections: Injected “doses”...

  • Page 24: Manage Your Recorded Data

    MANAGE YOUR RECORDED DATA You can manage and edit the following list of items: - You can change a “priming” or a “dose” quantity (see section 7.2.1.), - You can change an injection recorded as a “dose” to a “priming”, or a “priming” to a “dose” (see section 7.2.2.), - You can delete a “dose”...

  • Page 25: You Can Delete A "Dose" Or A "Priming

    7.2.3 YOU CAN DELETE A “DOSE” OR A “PRIMING” 7.2.4 YOU CAN ADD AN INJECTION THAT WAS NOT RECORDED TO THE HISTORY Page 21 / 41 IFU_MAL_EN_V6...

  • Page 26: You Can Fill In A Dose That Was Not Captured By The Device

    The information “Dose not recorded” is displayed if a disturbance occurs during the injection. You can add the dose information as follows: to modify the information related to the injection: OTHER FEATURES OF THE MALLYA APPLICATION 7.3.1 GENERATE A REPORT “Injections”...

  • Page 27: Pair Two Mallya Devices To Your Mobile Application

    7.3.2 PAIR TWO MALLYA DEVICES TO YOUR MOBILE APPLICATION Mallya “Devices” screen Both Mallya devices with associated insulin pens are activated and can be used independently. They both have the status “Ready”. WARNING Make sure you do not switch the pens between the two Mallya devices.

  • Page 28: Settings

    , 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: “This Mallya is connected” or “This mallya is disconnected since …”...
  • Page 29 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 section 9.3. - Reset Instructions.

  • Page 30: Help" Screen

    REMOVE 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.
  • Page 31 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.
  • Page 32 5.4.2.3., 5.4.2.4., and 5.4.2.5. are displayed in the injection history as if no displayed. You have to select the new pen mounting event had taken place. model on which your Mallya is currently assembled. Example with the The new pen model currently assembled “LANTUS”...
  • Page 33 Your smartphone may disconnect from the Mallya system in case 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.
  • Page 34 BIOCORP PRODUCTION authorized dealer. TROUBLESHOOTING MALLYA WITH VISUAL AND AUDITIVE 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:...
  • Page 35 In this case, it is necessary to: - adjust and align the position of the windows: - or to raise or lower the position of the Mallya base on the pen, - or, to push the Mallya button onto the pen,...
  • Page 36 BIOCORP PRODUCTION authorized dealer. INDICATION CAUSE TROUBLESHOOTING STEPS ① Select: “Not Ready” ② Check that the Mallya device is correctly Mallya’s base not detected assembled on the pen (see section 5.3.) ① Select: “Not Ready” ② Turn the button of the pen back to the...
  • Page 37 ① Select “Disconnected” ② Reset Mallya as explained in the Mallya A communication error occurred device instructions for use (see section 9.3.) ① Check that the Mallya device is powered ② Check that the Mallya device is connected ③...
  • Page 38 Check each week on your smartphone that there is no Mallya application update 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.
  • Page 39 - Disconnect the USB cable before cleaning Mallya. CAUTION - 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.
  • Page 40 11. TECHNICAL SPECIFICATIONS & PERFORMANCES 11.1 ELECTRICAL RATINGS CAUTION Make sure you connect the Mallya USB cable to a power source compliant with the IEC 60601-1. USB CHARACTERISTICS Input voltage 5V DC 2A Min Current 500mA Ingress Protection IP 22...
  • Page 41 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The Mallya is intended for use in the electromagnetic environment specified below. The operator of the Mallya should ensure that it is used in such an environment. Emission test Compliance...
  • Page 42 GUIDANCE AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY The Mallya is intended for use in the electromagnetic environment specified below. The operator of the Mallya should ensure that it is used in such an environment. CEI 60601 test Electromagnetic environment -...
  • Page 43 You can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communication devices (transmitters) and the Mallya device as recommended below, according to the maximum output power of the radio communications devices...
  • Page 44 GUIDANCE AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY The Mallya is intended for use in the electromagnetic environment specified below. The operator of the Mallya must ensure that it is used in such an environment. Compliance Electromagnetic...
  • Page 45 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.

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