BIOCORP Mallya User manual

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

IFU_MAL_EN_V6
TABLE OF CONTENTS
1. GENERAL INFORMATION .............................................................................................................2
2. MALLYA COMPATIBILITIES – MOLECULES AND CONCENTRATIONS...................................2
3. DEVICE DESCRIPTION AND EXAM ENVIRONMENT..................................................................3
3.1 DEVICE DESCRIPTION .........................................................................................................3
3.1.1 MALLYA CHARACTERISTICS...........................................................................................3
3.1.2 ESSENTIAL PERFORMANCES OF THE SYSTEM (SIGNIFICANT OPERATING
CHARACTERISTICS)......................................................................................................................3
3.1.3 MALLYA PARTS REFERENCES .......................................................................................3
3.2 WEIGHT AND SIZE OF THE MAIN ELEMENTS ...................................................................4
4. SAFETY INFORMATION ................................................................................................................4
4.1 SYMBOLS ON THE DEVICE AND ITS PACKAGING ............................................................4
4.2 WARNINGS AND CAUTIONS ................................................................................................5
4.3 ELECTRICAL SAFETY ...........................................................................................................6
4.4 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS ..................7
4.5 MALLYA BASE LABELING.....................................................................................................7
4.6 TRANSPORT AND STORAGE CONDITIONS .......................................................................8
4.7 USAGE CONDITIONS ............................................................................................................8
4.8 DISPOSAL ..............................................................................................................................8
5. UNPACKING AND INSTALLING MALLYA (CHARGING / CALIBRATING / ASSEMBLING /
PAIRING)..................................................................................................................................................9
5.1 UNPACKING YOUR MALLYA AND ITS ACCESSORIES......................................................9
5.1.1 PACKAGE CONTENTS......................................................................................................9
5.1.2 UNPACKING.......................................................................................................................9
5.2 CHARGING AND CALIBRATING YOUR MALLYA ............................................................. 10
5.2.1 CHARGING YOUR MALLYA........................................................................................... 10
5.2.2 CALIBRATING YOUR MALLYA ...................................................................................... 11
5.3 ASSEMBLING YOUR MALLYA TO THE INSULIN PEN ..................................................... 12
5.3.1 ATTACHING BASE TO PEN ........................................................................................... 12
5.3.2 ATTACHING BUTTON TO PEN...................................................................................... 12
5.4 PAIRING MALLYA WITH YOUR SMARTPHONE ............................................................... 13
5.4.1 INSTALLING THE MALLYA MOBILE APPLICATION..................................................... 13
TECHNICAL COMPATIBILITIES ................................................................................ 13
DOWNLOAD THE MALLYA APPLICATION AND GET STARTED ............................ 13
5.4.2 PAIRING .......................................................................................................................... 13
6. OPERATING INSTRUCTIONS .................................................................................................... 17
6.1 SECURITY TEST - PRIMING .............................................................................................. 17
6.2 INJECTION .......................................................................................................................... 18
7. MANAGE RECORDED DATA ..................................................................................................... 19
7.1 DISPLAY OF THE RECORDED DATA ............................................................................... 19
7.2 MANAGE YOUR RECORDED DATA .................................................................................. 20
7.2.1 YOU CAN CHANGE A “PRIMING” OR A “DOSE” QUANTITY ....................................... 20
7.2.2 YOU CAN CHANGE AN INJECTION RECORDED AS A “DOSE” TO A “PRIMING”, OR A
“PRIMING” TO A “DOSE” ............................................................................................................. 20
7.2.3 YOU CAN DELETE A “DOSE” OR A “PRIMING”............................................................ 21
7.2.4 YOU CAN ADD AN INJECTION THAT WAS NOT RECORDED TO THE HISTORY .... 21
7.2.5 YOU CAN FILL IN A DOSE THAT WAS NOT CAPTURED BY THE DEVICE ............... 22
7.3 OTHER FEATURES OF THE MALLYA APPLICATION ...................................................... 22
7.3.1 GENERATE A REPORT.................................................................................................. 22
7.3.2 PAIR TWO MALLYA DEVICES TO YOUR MOBILE APPLICATION.............................. 23
7.3.3 SETTINGS ....................................................................................................................... 24
7.3.4 “HELP” SCREEN ............................................................................................................. 26

IFU_MAL_EN_V6
8. TRANSFERRING MALLYA TO A NEW PEN.............................................................................. 26
8.1 REMOVE MALLYA FROM THE EMPTY PEN..................................................................... 26
8.2 ATTACH YOUR MALLYA TO A NEW PEN......................................................................... 27
8.3 COLLECT YOUR INJECTION DATA FROM MALLYA AFTER SMARTPHONE
DISCONNECTION ............................................................................................................................ 29
9. TROUBLESHOOTING ................................................................................................................. 30
9.1 TROUBLESHOOTING MALLYA WITH VISUAL AND AUDITIVE BASE SIGNALS............ 30
9.2 TROUBLESHOOTING MALLYA WITH THE APPLICATION .............................................. 32
9.3 RESET INSTRUCTIONS ..................................................................................................... 34
10. MAINTENANCE AND INSPECTION................................................................................... 34
10.1 MALLYA DEVICE LIFETIME ............................................................................................... 34
10.2 MALLYA APPLICATION UPDATES .................................................................................... 34
10.3 CLEANING YOUR MALLYA ................................................................................................ 34
10.4 MAINTAIN WATER, DUST AND LIGHT RESISTANCE...................................................... 35
11. TECHNICAL SPECIFICATIONS & PERFORMANCES...................................................... 36
11.1 ELECTRICAL RATINGS ...................................................................................................... 36
11.2 MATERIALS ......................................................................................................................... 36
11.3 ACCURACY ......................................................................................................................... 36
12. ELECTROMAGNETIC COMPATIBILITY............................................................................ 37
12.1 GENERAL PRECAUTIONS AND WARNINGS ................................................................... 37
12.2 ELECTROMAGNETIC EMISSIONS .................................................................................... 37
12.3 INTERFERENCE IMMUNITY .............................................................................................. 38
12.4 ELECTROMAGNETIC IMMUNITY ...................................................................................... 40
13. DISCLAIMER ....................................................................................................................... 41
TABLES LIST
TABLE 1 - SYMBOLS USED IN IFU 4
TABLE 2 - ABREVIATIONS LIST 4
TABLE 3 - MALLYA COMPATIBILITIES – MOLECULES AND CONCENTRATIONS 2
TABLE 4 - MALLYA PARTS NUMBERS 3
TABLE 5 - PARTS NECESSARY FOR OPERATION 4
TABLE 6 - WEIGHT AND SIZE OF THE MAIN ELEMENTS 4
TABLE 7 - SYMBOLS ON THE DEVICE AND ITS PACKAGING 4
TABLE 8 - SYMBOLS ON THE DEVICE AND ITS PACKAGING (SUITE) 5
TABLE 9 - MAINS STANDARDS & CLASSIFICATION 7
TABLE 10 - MALLYA BASE AND BUTTON LABELING 7
TABLE 11 – TRANSPORT AND STORAGE CONDITIONS 8
TABLE 12 - USAGE CONDITIONS 8
TABLE 13 - PACKAGE CONTENT 9
TABLE 14 - TROUBLESHOOTING WITH VISUAL AND AUDITIVE BASE SIGNALS 30
TABLE 15 - TROUBLESHOOTING WITH APP. 32
TABLE 16 - TROUBLESHOOTING WITH APP. (NEXT) 33
TABLE 17 - MALLYA ELECTRICAL INFORMATION 36
TABLE 18 – BATTERY CHARGING INFORMATION 36
TABLE 19 - MATERIALS 36
TABLE 20 – ACCURACY ON TEST BENCH 36
TABLE 21 - EXTERNAL FACTORS AND ACCURACY OF THE DISPLAYED VALUE 36
TABLE 22 - ELECTROMAGNETIC EMISSIONS 37
TABLE 23 - ELECTROMAGNETIC IMMUNITY 38
TABLE 24 - RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE & RF 39
TABLE 25 - ELECTROMAGNETIC IMMUNITY 40

IFU_MAL_EN_V6
SYMBOLS USED IN THIS MANUAL
Symbol Meaning Explanation
WARNING
Improper operation may result in serious
injury*1or 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
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 Part Number
SN Serial Number
LED
Light indicator
(Light Emitting Diode)
IP
Ingress Protection
BLE Bluetooth Low Energy
Table 2 - Abbreviations list

Page 1 / 41 IFU_MAL_EN_V6
Device features
Mallya is composed of a base and a button that can be mounted on a disposable insulin pen.
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.
The Mallya System aims to help patients keep accurate records of their insulin injections
(without providing specific treatment or treatment suggestions). The device’s purpose is to help
patients improve adherence to their treatment and share data with healthcare professionals.
Intended use
Mallya 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 Mallya device are patients with type I and II diabetes. Mallya is a
reusable device intended for a single patient.
Usage environment
The Mallya device is intended for use in a medical office or at home.
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: [e-mail]
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.
Mallya
base
Mallya
button

Page 2 / 41 IFU_MAL_EN_V6
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 Mallya unit (this SN number can be found on the device label)
2. MALLYA COMPATIBILITIES – MOLECULES AND
CONCENTRATIONS
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:
MALLYA MODEL INSULINE INN CONCENTRATION
WARNING
EXCLUDED
VERSIONS
MALLYA IS NOT
COMPATIBLE WITH
THE FOLLOWING
INSULIN PENS:
Mallya designed for
KWIKPEN®ELI LILLY
insulin pen
GLARGINE
100 IU/mL
LISPRO
100 IU/mL
Humalog Junior
200 IU/mL
LISPRO AND
PROTAMINE
100 IU/mL
HUMAN ISOPHANE
100 IU/mL
REGULAR HUMAN USP
100 IU/mL
REGULAR HUMAN AND
HUMAN ISOPHANE
100 IU/mL
Mallya designed for
FLEXPEN® NOVO NORDISK
insulin pen
DETEMIR
100 IU/mL
ASPART
100 IU/mL
ASPART AND
PROTAMINE
100 IU/mL
HUMAN ISOPHANE
100 IU/mL
Mallya designed for
SOLOSTAR® SANOFI
insulin pen
GLARGINE
100 IU/mL
300 IU/mL
Toujeo Max
Toujeo Doublestar
LISPRO
100 IU/mL
GLULISINE
100 IU/mL
GLARGINE AND
LIXISENATIDE
100 IU/mL
+33 mcg/mL
Table 3 - Mallya compatibilities – Molecules and concentrations

Page 3 / 41 IFU_MAL_EN_V6
3. DEVICE DESCRIPTION AND EXAM ENVIRONMENT
3.1 DEVICE DESCRIPTION
3.1.1 MALLYA CHARACTERISTICS
The Mallya device is composed of a base and a button:
BASE
BUTTON
3.1.2 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:
-Injected Insulin Dosage (UI)
-Injection Date
-Injection Hour
The compatible Mallya mobile application allows the patient to securely display treatment
information. This improves the patient’s therapeutic adherence.
3.1.3 MALLYA PARTS REFERENCES
The references (Part Numbers) vary depending on the Mallya model:
MALLYA MODEL
MALLYA BASE
APPLIED PART
MALLYA BUTTON
APPLIED PART
Mallya designed for
FLEXPEN® NOVO NORDISK
insulin pen
PN : 0273778
PN : 0273727
Mallya designed for
KWIKPEN®ELI LILLY insulin
pen
PN : 0273694
PN : 0273698
Mallya designed for
SOLOSTAR® SANOFI insulin
pen
PN : 0273777
PN: 0273710
Table 4 - Mallya parts numbers
Micro
USB port
Clear square
dose window
LED
Button

Page 4 / 41 IFU_MAL_EN_V6
The following parts are necessary to operate the Mallya device:
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.
3.2 WEIGHT AND SIZE OF THE MAIN ELEMENTS
ELEMENT
WEIGHT
INSULIN PEN
SIZE
Mallya base 0,016 kg
KWIKPEN®
(60.8x28.9x21.3) mm
FLEXPEN®
(60.8x26.9x21.3) mm
SOLOSTAR®
Mallya button 0,006 kg
KWIKPEN®
(11.6 x Ø22) mm
FLEXPEN®
(26.3 x Ø19.3) mm
SOLOSTAR®
(24.4 x Ø20) mm
Mallya 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 Refer to the instructions for use
DEVICE AND PACKAGING Manufacturer
DEVICE AND PACKAGING CE marking: product conform to CE
regulations
DEVICE AND PACKAGING Serial Number
DEVICE AND PACKAGING Manufacturing date
PACKAGING Batch Number
PACKAGING International and unique item code
(Global Trade Item Number)
Table 7 - Symbols on the device and its packaging

Page 5 / 41 IFU_MAL_EN_V6
SYMBOL
LOCATION
DESCRIPTION
DEVICE AND PACKAGING Product reference
PACKAGING Distributor reference
PACKAGING Class II device (double isolation)
-)
PACKAGING Type BF applied part
PACKAGING
Protection index IP22 (see section
10.4.: 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:
-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).
-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 Mallya warranty.
-Protect your personal health data by using a password on your smartphone.
-Periodic maintenance of Mallya is not required, only daily inspection is recommended.
Maintenance of the Mallya 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 / 41 IFU_MAL_EN_V6
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 Mallya
from the USB cable before using it.
-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.
-Do not attach or tighten cable to or around the head or neck. Cable can cause
strangulation.
-Avoid using near PACEMAKERS and DEFIBRILLATORS.
-Mallya 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
Mallya. Continued use may cause fire or device malfunction. Contact your authorized
BIOCORP PRODUCTION dealer for inspection.
- Mallya 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 Mallya 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 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 edges that may
cause injuries or may detach and create a choking hazard.
-Animals or insects: Do not leave your Mallya 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
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.
CAUTION
Connect the Mallya USB cable to a power source compliant with the IEC 60601-1.

Page 7 / 41 IFU_MAL_EN_V6
4.4 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS
COMPLIANT
STANDARDS
DESCRIPTION CLASSIFICATION
IEC 60601-1
•Protection type against electric shock
Class II (double isolation)
•Degree of protection against electric
shock
Type BF
•Mode of operation Continuous operation
IEC 60601-1-2
•Electromagnetic compatibility
* Refer to EMC section 12
IEC 60529
•
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 MALLYA BASE LABELING
MALLYA type BASE LABELING
BUTTON
MARKINGS
(INSIDE)
Mallya designed
for FLEXPEN®
NOVO
NORDISK insulin
pen
Mallya designed
for KWIKPEN®
ELI LILLY insulin
pen
Mallya designed
for SOLOSTAR®
SANOFI insulin
pen
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.
0273698

Page 8 / 41 IFU_MAL_EN_V6
4.6 TRANSPORT AND STORAGE CONDITIONS
Temperature
Atmospheric
pressure
Relative humidity
Transport
–10°C to +40°C
(14°F < T° < 104°F)
500 hPa to 1060 hPa 10% to 90%
Storage
–10°C to +40°C
(14°F < T° < 104°F)
800 hPa to 1060 hPa 10% to 90%
Table 11 – Transport and storage conditions
CAUTION
-The device must be transported and stored in its original packaging designed to protect it
from damage.
-Storage and transport conditions must meet conditions described in the above table.
4.7 USAGE CONDITIONS
Temperature
Atmospheric
pressure
Relative humidity
Operating
+15°C to +35°C
(59°F < T° < 95°F)
800 hPa to 1060 hPa 30% to 70%
Table 12 - Usage conditions
CAUTION
-Leave the device in a room for 30 minutes before unpacking to ensure there is no
condensation.
4.8 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
section 9.3.)

Page 9 / 41 IFU_MAL_EN_V6
5. UNPACKING AND 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 HUMALOG®JUNIOR)
Solostar®Sanofi (except for TOUJEO®MAX and TOUJEO®DOUBLESTAR)
Refer to section 2 – Mallya compatibilities – Molecules and concentrations
5.1 UNPACKING YOUR MALLYA AND ITS ACCESSORIES
5.1.1 PACKAGE CONTENTS
Mallya base (x1) Mallya button (x 2)
USB Cable (x 1) Reset Key (x 1)
Quick Start Guide with reference: QSG_MAL_AN (x 1)
Table 13 - Package content
5.1.2 UNPACKING
STEP 1 – Open the Mallya shipping box
Mallya is packed for shipping / transportation in a cardboard box:
The internal cardboard housing with special shaped forms and cardboard parts supports the
Mallya base and the button.

Page 10 / 41 IFU_MAL_EN_V6
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.
STEP 2 – Remove from the box: the base, the button and the accessories
You can get Mallya free support @ my-mallya.com
5.2 CHARGING AND CALIBRATING YOUR MALLYA
5.2.1 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.
-Never use your Mallya for an injection while it is connected to a USB power port and
charging.
Plug the powered USB cable into
the Mallya micro-USB port.
Check that the Mallya 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 Mallya’s battery is fully charged. You can then use
Mallya for at least 2 weeks.

Page 11 / 41 IFU_MAL_EN_V6
5.2.2 CALIBRATING YOUR MALLYA
Disconnect the USB cable from
the Mallya base.
Check that the Mallya LED is
flashing orange.
Slowly tilt the Mallya 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 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 12 / 41 IFU_MAL_EN_V6
5.3 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 the clear square
plastic window is facing
you
Align the Mallya base clear
square plastic window with
the pen dose window, then
snap the base
onto the
pen.
Make sure the Mallya base
window is perfectly aligned
with the pen dose window.
NOTE:
A pen symbol is represented on the
side of the Mallya base to help you
position the pen in the correct
orientation (square window oriented
toward the top of the pen).
5.3.2 ATTACHING BUTTON TO PEN
Align the Mallya button’s grooves with the
dose injection button’s notches, then
insert the Mallya
button onto the pen
injection button. Make sure the button is
properly attached and fully inserted.
The Mallya base LED will flash orange
and green when the button and base are
properly mounted onto the pen and when
the Mallya device is not yet paired.

Page 13 / 41 IFU_MAL_EN_V6
5.4 PAIRING MALLYA WITH YOUR SMARTPHONE
5.4.1 INSTALLING THE “MALLYA” MOBILE APPLICATION
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 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
Download the Mallya application from:
Once installed, select the following icon to open up the application:
The first time you open the application, you are prompted to choose the country in which your
insulin was prescribed:
NOTE:
The application is going to be configured with compliant insulins available in the chosen
country. A change of this setting would require a complete new installation of the application.
Then:
-the Mallya application General Terms & Conditions of Use (T&Cs) screen is displayed.
Please read the terms of use before accepting them and then confirm your choice.
-the Privacy Policy screen is then displayed: make sure you understand it, before
accessing the “Get Started” screen:

Page 14 / 41 IFU_MAL_EN_V6
5.4.1.2.1 Select: "Get started":
5.4.1.2.2 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 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. Assembling your Mallya to the insulin pen)
-Pair (as explained in the following section 5.4.2. Pairing your Mallya)

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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
30 cm of your smartphone and
select “Start pairing”:
Select “Pair”
NOTE:
The pairing step may take few seconds.
Choose the insulin pen model onto
which the Mallya device is
assembled from the proposed list.
Confirm the pen model currently
assembled with the Mallya
device.
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 device.
NOTE:
If you select “No, it does not match”, the
application will return to the previous
screen (section 5.4.2.3.) to let you choose
another pen model.

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Your Mallya device is now paired
with the Mallya application on your
smartphone.
Select “OK” to move on to the
injection screen.
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.
When Mallya is paired to the compatible mobile application and correctly attached to the
insulin pen: the Mallya LED is green.
NOTE:
The LED of Mallya is green when:
-the device is ready for use, or
-the dose setting is in progress, or
-the injection is in progress.