01-2021 Instructions For Use ® Designed for Flexpen® Novo Nordisk Designed for Kwikpen® Eli Lilly Designed for Solostar® Sanofi Embedded software versions 3.6. and over Helping you keep track of your insulin doses IFU_MAL_US_V1.
TABLE OF CONTENTS P. SYMBOLS IN THESE INSTRUCTIONS FOR USE ................................................................................... 4 STORAGE .................................................................................................................................................. 4 WARNINGS & CAUTIONS ........................................................................................................................ 5 FCC STATEMENTS ....................................................
8. TRANSFERRING MALLYA TO A NEW PEN ................................................................................. 28 8.1 REMOVING MALLYA FROM THE EMPTY PEN .................................................................... 28 8.2 TRANSFERRING MALLYA TO A NEW PEN WITH SELECTING THE “MOVE MALLYA TO A NEW PEN” BUTTON ............................................................................................................................ 28 8.
SYMBOLS IN THESE INSTRUCTIONS FOR USE Symbol Meaning Signification WARNING Improper operation may result in serious injury*1 or death to the user, patient CAUTION 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 CAUTION Consult the Instructions for Use documents CAUTION Do not use if the packaging is damaged Table 1 - Symbols used in these IFU (Instructions f
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.
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.
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).
1. MALLYA COMPATIBILITIES WITH PENS WARNING Make sure Mallya is compatible with your pen (insulin type and concentration).
2. GETTING TO KNOW YOUR MALLYA DEVICE 2.1 GETTING STARTED The shipment box contains the following items.
2.2 FEATURES OF YOUR MALLYA LED Micro USB port Knob Clear square dose window 2.3 WEIGHT AND SIZE OF THE MAIN ELEMENTS Element Weight Mallya base 0.016 kg Mallya knob 0.006 kg Mallya total weight Size KWIKPEN® base: (60.8x28.9x21.3) mm FLEXPEN® and SOLOSTAR® bases: (60.8x26.9x21.3) mm KWIKPEN® knob: (11.6 x Ø22) mm SOLOSTAR® knob: (24.4 x Ø20) mm FLEXPEN® knob: (26.3 x Ø19.3) mm 0.022 kg Table 4 - Weight and size of the main elements 2.
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.
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.
4. CARING FOR YOUR MALLYA 4.1 CHARGING YOUR MALLYA NOTE: 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. You cannot use your Mallya for an injection while it is connected to a USB power port and 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.
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.
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 is aligned with the pen dose window.
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.
4.4 PAIRING YOUR MALLYA To pair the Mallya device to the BIOCORP Mallya application, follow the steps indicated below: 4.4.1. 4.4.2. Make sure the Mallya base is within 12 inches Select “Pair” of your smartphone and select “Start pairing”: NOTE: The pairing step may take few seconds. 4.4.3. 4.4.4. Choose the insulin pen model onto which the Confirm the pen model currently Mallya device is assembled. assembled with the Mallya device.
4.4.5. 4.4.6. Well done! Your Mallya device is now paired The injection screen is displayed. with the Mallya application on your smartphone. Select “OK” to move on to the injection screen. 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.
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 manufacturer’s 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.
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 manufacturer’s 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.
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.
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.
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.
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 7. to modify the information related to the injection: 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.
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.
7.3 Select 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: 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.
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.
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.
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.
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.
The following screen is displayed with 2 options to choose from: YES, this device is exclusively used with NO, I have placed this device on another the same type of pen (same as the original type of pen. pen). In this case, the injection dose will be 1) In this case, the screens in steps 4.4.3., displayed in the injection history as if no 4.4.4., and 4.4.5. are displayed. You have removal event had taken place. to select the new pen model on which your Mallya is currently assembled.
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.
9. TROUBLESHOOTING CAUTION - Never attempt to access the internal hardware for any purpose including maintenance in all circumstances. - 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.
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.
INFORMATIONS REGARDING OTHER SIGNALS: SIGNAL Green LED (slow flashing) Green LED CAUSE TROUBLESHOOTING STEPS Mallya is charging. (See step 4.1.) 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. Keep the needle in the skin: - During the whole time Mallya’s green LED is flashing, - Until Mallya emits an audible signal (BEEP) signaling the end of the injection.
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 Calibration error ① Select “Error” ② 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 ① Move your Mallya device and your smartphone closer to one another. A communication error occurred ① Select “Disconnected” ② Reset Mallya as explained in the Mallya device Instructions for Use (see step 9.3.
9.3 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. PROCEDURE: 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.
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.
- If the device is dropped or receives an impact, its water and dust resistance may be impaired. 11. TECHNICAL SPECIFICATIONS 11.
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.
SYMBOL STANDARDS DESCRIPTION Symbol 5.3.9 (ISO 7000Pressure limits within which the device can be safely 2621) of ISO 15223exposed 1:2012 Table 12 - Symbols on the device and its packaging (next) 11.4 ELECTRICAL RATINGS CAUTION Make sure you connect the Mallya USB cable to a power source compliant with the IEC 606011.
CAUTION External factors may affect the dose measurement accuracy. Factors Affect the measurement Ambient Temperature Magnetic disturbance Dose Knob position Does not affect the measurement √ √ √ Table 16 - External factors and measurement accuracy 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.
12. GENERAL INFORMATION BIOCORP PRODUCTION ZI LAVAUR LA BECHADE DISTRIBUTORS 63500 ISSOIRE (authorized dealers): CEDEX – FRANCE See list and contact information Tel : +33 4 73 55 70 50 at the end of leaflet www.biocorpsys.com 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.
