FAQ
General
questions
Mallya attaches to disposable insulin pens such as Solostar®, Flexpen® or Kwikpen®. Mallya collects the data of your insulin injections and transmits it reliably and securely to your smartphone via Bluetooth.
Mallya received the CE IIb approval in 2019 and obtained 510(k) FDA clearancein 2022.
The on-board technology consists of measuring a magnetic field and translating it into a dose of insulin. This data is then transmitted via Bluetooth to your smartphone.
Mallya allows you to better manage your diabetes by automatically collecting data about your insulin injections and transferring this data to your doctor or diabetes specialist. Mallya is currently the only device in its category to be CE Medical Device Class II-b marked. (CE0459)
You do not need to sign up or create a personal account to use the Mallya device.
Absolutely, it is even recommended to use 2 Mallya devices, one for each of your insulins: you then have all your insulin data in your logbook. Due to the differences between pens of different brands, 3 models of Mallya are currently available: Mallya for Solostar – Mallya for Flexpen – Mallya for Kwikpen.
It is not recommended to transfer Mallya from one pen to another, except to replace the pen when it is empty.
First of all, there is one Mallya model per pen type due to the ergonomic differences between brands. Today there are 3 different Mallya models available: Mallya for Solostar, Mallya for Kwikpen and Mallya for Flexpen.
Then, for practical reasons, it is best to leave Mallya mounted on your pen. If you use 2 different insulins from Sanofi for example and you have only one Mallya for Solostar, you can fix Mallya to one pen and then the other, but you will have to be very careful to select the right insulin in the App each time you mount/dismount it. We strongly recommend you to always use one Mallya for each pen.
Mallya is compatible with most pens available on the market. For a list of compatible pens, please refer to Mallya instructions for use (see your country page )
It is not possible with the current version of the device to use the same Mallya device on two apps. This means that a connected device can be paired with only one app. But you can pair 2 Mallya with one app.
No medical clearance is required to use Mallya, however it is recommended that you talk about it with your doctor.
Once installed on your pen, Mallya does not interfere with the way you are used to inject your insulin. However, Mallya can guide you by indicating the end of your insulin injection with LED and sound signal. For more information, please refer to the instructions for your insulin pen and the Mallya instructions for use.
Technical
questions
First you need to plug in Mallya using the USB cable provided in the box and connect it to a charger. Once plugged in, check that the LED turns green and that its intensity varies slowly. Let the battery charge for ten minutes, then disconnect the USB cable and check that the LED flashes orange: you can now calibrate Mallya.
Simply tilt the Mallya base slowly to one side and then to the other when it flashes orange. Continue doing this until you hear a beep and the LED turns green and then turns off.
Fast flashing: calibration is in progress.
Slow flashing: battery is low. Plug in and leave to charge for about 2 hours for a full charge.
When you turn Mallya on for the first time, simply plug it in with its USB cable powered for 10 minutes to “wake it up”. You can then calibrate and pair Mallya for use.
A full battery charge lasts approximately 2 hours.
The LED will slowly flash orange. You should then connect Mallya with the supplied USB cable and let it charge for about 2 hours for optimum charging.
This depends on how often you use Mallya. However, with 3 to 4 injections daily, Mallya will need to be recharged once or twice a month.
It is expected to last a minimum of two years.
Hold the Mallya base so that the square window of the transparent part is facing you. Align this window with the dose window of your pen and clip the base onto the pen. Warning: the two windows must be perfectly superimposed. Then insert the button on the dose injection button of your pen. Once assembled, the LED will flash orange and green if Mallya is not yet paired with your smartphone. If Mallya is already paired with your smartphone, the LED will display green and then turn off.
Check the alignment of Mallya’s window and the pen. Check that the button is pressed in correctly.
Security
& confidentiality
The collected data is stored in the internal memory of Mallya.
Mallya incorporates appropriate technical security measures to maintain the security and confidentiality of your data to prevent it from being distorted, damaged, disclosed and accessed by unauthorized third parties.
You are the only one to have access to this data and may choose to share it with a third party, such as a family member or healthcare professional.
The Mallya App stores the last 100 insulin deliveries.
All data collected in Mallya’s internal memory is erased by resetting it.
In accordance with the applicable regulations and under the conditions defined therein, you may at any time exercise your rights (data access, data rectification, data erasure, objection, portability and limitation to data processing) by unchecking the dedicated tick box in the mobile app with regards to navigation data, or by resetting the Mallya App with regard to data related to dose, date and time of injection.
Mallya mobile
application
The app complements the use of the Mallya medical device. It allows you to view your insulin injection data: dose injected, date, time, insulin type. In addition to the injection log, the application offers the possibility to create a report that can be shared with a healthcare professional.
The Mallya App is available on the Apple Store (iPhone) and the Play Store (Android). The application is installed in a traditional way: simply click on ‘get/install’ and the application will be automatically installed on your smartphone.
After downloading the Mallya App, simply activate Bluetooth on your phone and bring the Mallya device closer to your smartphone. The app will ask you to wait a few seconds and that’s it!
As soon as Mallya is close to your phone, the data will be uploaded to the App. You therefore do not need to have your phone with you when you inject, the synchronization can be done automatically later.
You don’t need to be connected to the app when you make an injection. Mallya saves the data without being logged in. When you want to retrieve it on the App, you simply activate Bluetooth and bring Mallya next to your smartphone. If Bluetooth is always enabled on your phone, you don’t have to do anything.
You can pair two Mallya with the App to manage your rapid and basal insulin, for example. Simply go to the App, click on “Devices” and then “Pair a new Mallya”.
You can’t use multiple apps at the same time. During the pairing phase, a secure connection is created between Mallya and the app, prohibiting it from pairing with another application for data security reasons (personal and health). If you wish to pair Mallya with a different application, you will need to reset it.
You can pair Mallya with the App when your phone is not connected to the internet, simply activate Bluetooth.
You can share your data with anyone you want, whether they are family members or healthcare people. Data sharing is specific to the Mallya app. To share your data, simply click on “report” which will generate a PDF report on a chosen period of time. Once created, this report is stored in your smartphone. You can then send it (by email, sms, etc.) to whomever you wish.
Other subjects
First of all, please refer to the Mallya user manual available for download just above the FAQ section.
If you still can’t find the answer to your problem, please contact the support department of the authorized country distributor.
General
questions
Mallya attaches to disposable insulin pens such as Solostar®, Flexpen® or Kwikpen®. Mallya collects the data of your insulin injections and transmits it reliably and securely to your smartphone via Bluetooth.
Mallya received the CE IIb approval in 2019 and obtained 510(k) FDA clearancein 2022.
The on-board technology consists of measuring a magnetic field and translating it into a dose of insulin. This data is then transmitted via Bluetooth to your smartphone.
Mallya allows you to better manage your diabetes by automatically collecting data about your insulin injections and transferring this data to your doctor or diabetes specialist. Mallya is currently the only device in its category to be CE Medical Device Class II-b marked. (CE0459)
You do not need to sign up or create a personal account to use the Mallya device.
Absolutely, it is even recommended to use 2 Mallya devices, one for each of your insulins: you then have all your insulin data in your logbook. Due to the differences between pens of different brands, 3 models of Mallya are currently available: Mallya for Solostar – Mallya for Flexpen – Mallya for Kwikpen.
It is not recommended to transfer Mallya from one pen to another, except to replace the pen when it is empty.
First of all, there is one Mallya model per pen type due to the ergonomic differences between brands. Today there are 3 different Mallya models available: Mallya for Solostar, Mallya for Kwikpen and Mallya for Flexpen.
Then, for practical reasons, it is best to leave Mallya mounted on your pen. If you use 2 different insulins from Sanofi for example and you have only one Mallya for Solostar, you can fix Mallya to one pen and then the other, but you will have to be very careful to select the right insulin in the App each time you mount/dismount it. We strongly recommend you to always use one Mallya for each pen.
Mallya is compatible with most pens available on the market. For a list of compatible pens, please refer to Mallya instructions for use (see your country page )
It is not possible with the current version of the device to use the same Mallya device on two apps. This means that a connected device can be paired with only one app. But you can pair 2 Mallya with one app.
No medical clearance is required to use Mallya, however it is recommended that you talk about it with your doctor.
Once installed on your pen, Mallya does not interfere with the way you are used to inject your insulin. However, Mallya can guide you by indicating the end of your insulin injection with LED and sound signal. For more information, please refer to the instructions for your insulin pen and the Mallya instructions for use.
Technical
questions
First you need to plug in Mallya using the USB cable provided in the box and connect it to a charger. Once plugged in, check that the LED turns green and that its intensity varies slowly. Let the battery charge for ten minutes, then disconnect the USB cable and check that the LED flashes orange: you can now calibrate Mallya.
Simply tilt the Mallya base slowly to one side and then to the other when it flashes orange. Continue doing this until you hear a beep and the LED turns green and then turns off.
Fast flashing: calibration is in progress.
Slow flashing: battery is low. Plug in and leave to charge for about 2 hours for a full charge.
When you turn Mallya on for the first time, simply plug it in with its USB cable powered for 10 minutes to “wake it up”. You can then calibrate and pair Mallya for use.
A full battery charge lasts approximately 2 hours.
The LED will slowly flash orange. You should then connect Mallya with the supplied USB cable and let it charge for about 2 hours for optimum charging.
This depends on how often you use Mallya. However, with 3 to 4 injections daily, Mallya will need to be recharged once or twice a month.
It is expected to last a minimum of two years.
Hold the Mallya base so that the square window of the transparent part is facing you. Align this window with the dose window of your pen and clip the base onto the pen. Warning: the two windows must be perfectly superimposed. Then insert the button on the dose injection button of your pen. Once assembled, the LED will flash orange and green if Mallya is not yet paired with your smartphone. If Mallya is already paired with your smartphone, the LED will display green and then turn off.
Check the alignment of Mallya’s window and the pen. Check that the button is pressed in correctly.
Security
& confidentiality
The collected data is stored in the internal memory of Mallya.
Mallya incorporates appropriate technical security measures to maintain the security and confidentiality of your data to prevent it from being distorted, damaged, disclosed and accessed by unauthorized third parties.
You are the only one to have access to this data and may choose to share it with a third party, such as a family member or healthcare professional.
The Mallya App stores the last 100 insulin deliveries.
All data collected in Mallya’s internal memory is erased by resetting it.
In accordance with the applicable regulations and under the conditions defined therein, you may at any time exercise your rights (data access, data rectification, data erasure, objection, portability and limitation to data processing) by unchecking the dedicated tick box in the mobile app with regards to navigation data, or by resetting the Mallya App with regard to data related to dose, date and time of injection.
Mallya mobile
application
The app complements the use of the Mallya medical device. It allows you to view your insulin injection data: dose injected, date, time, insulin type. In addition to the injection log, the application offers the possibility to create a report that can be shared with a healthcare professional.
The Mallya App is available on the Apple Store (iPhone) and the Play Store (Android). The application is installed in a traditional way: simply click on ‘get/install’ and the application will be automatically installed on your smartphone.
After downloading the Mallya App, simply activate Bluetooth on your phone and bring the Mallya device closer to your smartphone. The app will ask you to wait a few seconds and that’s it!
As soon as Mallya is close to your phone, the data will be uploaded to the App. You therefore do not need to have your phone with you when you inject, the synchronization can be done automatically later.
You don’t need to be connected to the app when you make an injection. Mallya saves the data without being logged in. When you want to retrieve it on the App, you simply activate Bluetooth and bring Mallya next to your smartphone. If Bluetooth is always enabled on your phone, you don’t have to do anything.
You can pair two Mallya with the App to manage your rapid and basal insulin, for example. Simply go to the App, click on “Devices” and then “Pair a new Mallya”.
You can’t use multiple apps at the same time. During the pairing phase, a secure connection is created between Mallya and the app, prohibiting it from pairing with another application for data security reasons (personal and health). If you wish to pair Mallya with a different application, you will need to reset it.
You can pair Mallya with the App when your phone is not connected to the internet, simply activate Bluetooth.
You can share your data with anyone you want, whether they are family members or healthcare people. Data sharing is specific to the Mallya app. To share your data, simply click on “report” which will generate a PDF report on a chosen period of time. Once created, this report is stored in your smartphone. You can then send it (by email, sms, etc.) to whomever you wish.
Other subjects
First of all, please refer to the Mallya user manual available for download just above the FAQ section.
If you still can’t find the answer to your problem, please contact the support department of the authorized country distributor.