BIOCORP Mallya Instructions For Use Manual
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BIOCORP Mallya Instructions For Use Manual

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07-2020
Instructions For Use
®
®
®
®
Designed for Flexpen
Novo
Designed for Kwikpen
Eli Lilly
Designed for Solostar
Sanofi
Nordisk
Helping you keep track of your insulin doses
IFU_MAL_SLST_US_V1.7

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  • Page 1 07-2020 Instructions For Use ® ® ® ® Designed for Flexpen Novo Designed for Kwikpen Eli Lilly Designed for Solostar Sanofi Nordisk Helping you keep track of your insulin doses IFU_MAL_SLST_US_V1.7...

  • Page 2: Table Of Contents

    Make sure the Mallya smart base window is aligned with the pen dose window..........14 A pen symbol is represented on the side of the Mallya smart base to help you position the pen in the correct orientation. 14 8.3.2...
  • Page 3 Injection screen before transferring Mallya onto a new pen: ................. 28 12.2.2 Remove Mallya from the empty pen / attach Mallya onto a new pen (smart base and / or button) ..... 28 12.2.3 On the next PRIMING or an INJECTION: ......................28 ......................................

  • Page 4: Symbols In This Instructions For Use

    SYMBOLS IN THIS INSTRUCTIONS FOR USE Symbol Meaning Signification Improper operation may result in WARNING serious injury* or death to the user, patient Improper operation may result in CAUTION bodily injury* or property damage* Disconnect the device from power CAUTION supply before servicing/cleaning NOTE Important information for operation...

  • Page 5: Warning & Caution

    - Mallya is intended for Over the Counter use and is not a prescription device. - Mallya is supplied with a USB cable. Use the cable supplied with the device to connect it to a USB power port. Do not use any other cable. Other cables may create problems or interfere with other electronic devices.

  • Page 6: Directions For Use

    DIRECTIONS FOR USE FEATURES Mallya is composed of a smart base and a button that can be mounted on a disposable insulin pen. Mallya button Mallya smart base Mallya allows you to: - record the injected selected increment (insulin dose),...

  • Page 7: Mallya Compatibilities With Pens

    MALLYA COMPATIBILITIES WITH PENS WARNING Make sure your Mallya is compatible with your pen. MALLYA IS COMPATIBLE WITH THE PENS WITH THE FOLLOWING MOLECULES AND CONCENTRATIONS: ® ® ® Mallya for FLEXPEN Mallya for KWIKPEN Mallya for SOLOSTAR International non-...

  • Page 8: Getting To Know Your Mallya Device

    NOTE : Before you use your Mallya for the first time, you have to charge it. Use the provided USB cable to connect the Mallya smart base to a USB port or outlet. Let it charge for at least 10 minutes.

  • Page 9: Features Of Your Mallya

    FEATURES OF YOUR MALLYA Button Micro Clear square USB port dose window WEIGHT AND SIZE OF THE MAIN ELEMENTS Element Weight Size ® KWIKPEN smart base: (60.8x28.9x21.3) mm ® ® Mallya smart base 0.016 kg FLEXPEN and SOLOSTAR smart bases: (60.8x26.9x21.3) mm...

  • Page 10: Transport And Packaging

    Mallya connects your insulin pen to 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 the Mallya application Version 1.7.0 is shown below: SMARTPHONE MODEL...

  • Page 11: Download The Mallya Application And Get Started

    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.

  • Page 12: Caring For Your Mallya

    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 charging.

  • Page 13: Calibrating Your Mallya

    CALIBRATING YOUR MALLYA 8.2.1 Unplug the Mallya smart base from the USB cable. 8.2.2 Check that the Mallya LED is flashing orange. 8.2.3 Slowly tilt the Mallya smart base side to side to CALIBRATE. 8.2.4 Continue tilting until: ✓ The smart base beeps and the LED light turns green.

  • Page 14: Attaching Your Mallya To Pen

    ATTACHING YOUR MALLYA TO PEN CAUTION The Mallya smart base and button must be correctly attached onto the pen, otherwise, data will not be transferred. 8.3.1 ATTACHING SMART BASE TO PEN Hold the Mallya smart base so that the 8.3.1.1...
  • Page 15 Mallya smart 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,...

  • Page 16: Pairing Your Mallya

    PAIRING YOUR MALLYA To pair the Mallya device to the BIOCORP Mallya application, follow the steps indicated below: Select “Pair” 8.4.1 Make sure the Mallya smart base is 8.4.2 within 12 inches of your smartphone NOTE: and select “Start pairing”: The pairing step may take few seconds.

  • Page 17: Well Done! Your Mallya Device Is Now Paired With The Mallya Application On Your Smartphone

    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.

  • Page 18: Using Your Insulin Pen With Mallya

    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 manufacturer’s injector pen Instructions for Use. SECURITY TEST - PRIMING...

  • Page 19: Injection

    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.

  • Page 20: Managing Recorded Data

    10. 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: 10.1 DISPLAY OF THE RECORDED DATA Select the injection screen: “Doses” or “Priming” injections are then displayed as follows:...

  • Page 21: Manage Your Recorded Data

    10.2 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”...

  • Page 22: You Can Delete A "Dose" Or A "Priming

    10.2.3 You can delete a «dose» or a «priming» 10.2.4 You can add an injection that was not recorded to the history To add an unrecorded dose, select “Add to log”: P a g e 22 | 41 IFU_MAL_US_V1.7_July 2020...

  • Page 23: 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: to modify the information related to the injection: 11. OTHER FEATURES OF THE MALLYA APPLICATION 11.1 GENERATE A REPORT In the “Injections” screen, select the icon...

  • Page 24: Pair Two Mallya To Your Mobile App

    11.2 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.

  • Page 25: Settings

    Select 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.

  • Page 26: Help" Screen

    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.

  • Page 27: Transferring Mallya To A New Pen

    ✓ 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 ✓ get a new pen and inject the full dose: the Mallya application will display one full dose injection.

  • Page 28: Injection Screen Before Transferring Mallya Onto A New Pen

    Example: 12.2.1 Injection screen before transferring Mallya onto a new pen: 12.2.2 Remove Mallya from the empty pen / attach Mallya onto a new pen (smart base and / or button) 12.2.3 On the next PRIMING or an INJECTION: A “DEVICE REMOVAL” EVENT is detected!
  • Page 29 Select the following icon to choose the insuline type used for the injection: Example of the resulting screen with “Apidra” chosen: Apidra P a g e 29 | 41 IFU_MAL_US_V1.7_July 2020...

  • Page 30: Collect Your Injection Data From Mallya After Smartphone Disconnection

    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 31: Troubleshooting

    BIOCORP PRODUCTION authorized dealer. 13.1 TROUBLESHOOTING MALLYA WITH SMART 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: SIGNAL...
  • Page 32 - the injection is in progress Green LED (rapid flashing) Keep the needle in the skin: - During the whole time Mallya’s Mallya is at the end of an green LED is flashing, - Until Mallya emits an audible injection.

  • Page 33: Troubleshooting Mallya With The Application

    CAUSE TROUBLESHOOTING STEPS ① Select: “Not Ready” Mallya’s smart base ② Check that the Mallya device is correctly not detected assembled on the pen (see step 4.3.) ① Select: “Not Ready” ② Turn the knob button of the pen back to...
  • Page 34 ① Select “Disconnected” A communication ② Reset Mallya as explained in the Mallya error occurred device Instructions for Use (see step 9.3.) ① Check that the Mallya device is powered ② Check that the Mallya device is connected Bluetooth issue or to the App.

  • Page 35: Reset Instructions

    The reset procedure of Mallya may be necessary: - 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.

  • Page 36: Maintenance And Inspection

    14.1 MALLYA DEVICE LIFETIME Mallya and accessories lifetime is 2 YEARS. 14.2 MALLYA APPLICATION UPDATES Check each week on your smartphone (in the Apple store / Play store) that there is no Mallya application update available. 14.3 CLEANING YOUR MALLYA Periodic maintenance of your device is not required except for cleaning.

  • Page 37: Technical Specifications

    Table 9 - Compliance with standards / regulations and classifications 15.2 SMART BASE LABELLING MALLYA SENSOR TYPE LABELING Mallya smart base for insulin pen: ® FLEXPEN NOVO NORDISK Mallya smart base for insulin pen: ®...

  • Page 38: Symbols On The Device And Its Packaging

    15.3 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...

  • Page 39: Electrical Ratings

    Table 12 - Symbols on the device and its packaging (next) 15.4 ELECTRICAL RATINGS CAUTION Make sure you connect the Mallya USB cable to a power source compliant with the IEC 60601- USB CHARACTERISTICS Input voltage 5V DC 2A...

  • Page 40: Disposal

    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.) P a g e 40 | 41 IFU_MAL_US_V1.7_July 2020...

  • Page 41: 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) 17. DISCLAIMER The warranty is valid twelve months from the date of purchase.

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