BIOCORP Mallya Novo Nordisk User manual

01-2021
IFU_MAL_US_V1.13
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_V1.13_January 2021 P a g e 2 | 44
TABLE OF CONTENTS
P.
SYMBOLS IN THESE INSTRUCTIONS FOR USE ................................................................................... 4
STORAGE .................................................................................................................................................. 4
WARNINGS & CAUTIONS ........................................................................................................................ 5
FCC STATEMENTS ................................................................................................................................... 6
0. DIRECTIONS FOR USE .................................................................................................................... 7
0.1 FEATURES ............................................................................................................................... 7
0.2 INTENDED USE ........................................................................................................................ 7
1. MALLYA COMPATIBILITIES WITH PENS ....................................................................................... 8
2. GETTING TO KNOW YOUR MALLYA DEVICE ............................................................................... 9
2.1 GETTING STARTED ................................................................................................................. 9
2.2 FEATURES OF YOUR MALLYA ............................................................................................. 10
2.3 WEIGHT AND SIZE OF THE MAIN ELEMENTS .................................................................... 10
2.4 STORAGE INFORMATION ..................................................................................................... 10
2.5 TRANSPORT AND PACKAGING ........................................................................................... 11
3. INSTALLING THE MALLYA APPLICATION .................................................................................. 11
3.1 TECHNICAL COMPATIBILITIES ............................................................................................ 11
3.2 DOWNLOAD THE MALLYA APPLICATION AND GET STARTED ........................................ 12
4. CARING FOR YOUR MALLYA ....................................................................................................... 13
4.1 CHARGING YOUR MALLYA .................................................................................................. 13
4.2 CALIBRATING YOUR MALLYA .............................................................................................. 14
4.3 ATTACHING YOUR MALLYA TO PEN ................................................................................... 15
4.3.1 ATTACHING BASE TO PEN ................................................................................................... 15
4.3.2 ATTACHING KNOB TO PEN .................................................................................................. 15
4.4 PAIRING YOUR MALLYA ....................................................................................................... 17
5. USING YOUR INSULIN PEN WITH MALLYA ................................................................................ 19
5.1 SECURITY TEST - PRIMING ................................................................................................. 19
5.2 INJECTION .............................................................................................................................. 20
6. MANAGING RECORDED DATA ..................................................................................................... 21
6.1 DISPLAY OF THE RECORDED DATA .................................................................................. 21
6.2 MANAGE YOUR RECORDED DATA .................................................................................... 22
6.2.1 YOU CAN CHANGE A «PRIMING» OR A «DOSE» QUANTITY ALREADY RECORDED 22
6.2.2 YOU CAN CHANGE AN INJECTION RECORDED AS A «DOSE» TO A «PRIMING», OR A
«PRIMING» TO A «DOSE» ............................................................................................................. 22
6.2.3 YOU CAN DELETE A «DOSE» OR A «PRIMING» ............................................................ 23
6.2.4 YOU CAN ADD AN INJECTION THAT WAS NOT RECORDED TO THE HISTORY........ 23
6.2.5 YOU CAN FILL IN A DOSE THAT WAS NOT CAPTURED BY THE DEVICE .................. 24
7. OTHER FEATURES OF THE MALLYA APPLICATION ................................................................ 24
7.1 GENERATE A REPORT ......................................................................................................... 24
7.2 PAIR TWO MALLYA TO YOUR MOBILE APP. ...................................................................... 25
7.3 SETTINGS ............................................................................................................................... 26
7.4 “HELP” SCREEN ..................................................................................................................... 27

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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
8.3 TRANSFERRING MALLYA TO A NEW PEN WITHOUT SELECTING THE “MOVE MALLYA
TO A NEW PEN” BUTTON .................................................................................................................. 30
8.4 COLLECT YOUR INJECTION DATA FROM MALLYA AFTER SMARTPHONE
DISCONNECTION ............................................................................................................................... 32
9. TROUBLESHOOTING ..................................................................................................................... 33
9.1 TROUBLESHOOTING MALLYA WITH BASE SIGNALS ....................................................... 33
9.2 TROUBLESHOOTING MALLYA WITH THE APPLICATION .................................................. 36
9.3 RESET INSTRUCTIONS......................................................................................................... 38
10. MAINTENANCE AND INSPECTION ...................................................................................... 39
10.1 MALLYA DEVICE LIFETIME ................................................................................................... 39
10.2 MALLYA APPLICATION UPDATES ....................................................................................... 39
10.3 CLEANING YOUR MALLYA ................................................................................................... 39
10.4 MAINTAIN WATER, DUST AND LIGHT RESISTANCE ......................................................... 39
11. TECHNICAL SPECIFICATIONS ............................................................................................ 40
11.1 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS ................... 40
11.2 MALLYA BASE LABELLING ................................................................................................... 40
11.3 SYMBOLS ON THE DEVICE AND ITS PACKAGING ............................................................ 41
11.4 ELECTRICAL RATINGS ......................................................................................................... 42
11.5 MATERIALS ............................................................................................................................ 42
11.6 ACCURACY ............................................................................................................................ 42
11.7 DISPOSAL ............................................................................................................................... 43
12. GENERAL INFORMATION .................................................................................................... 44
13. DISCLAIMER .......................................................................................................................... 44

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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 for Use)
*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.
STORAGE
Store Mallya at room temperature between 59°F to 95°F (15°C to 35°C).
Keep Mallya away from:
 Water
 Pacemakers and defibrillators
 Metallic parts
 Small children. Your Mallya contains small parts that may cause injury or become a
choking hazard.

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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. 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 not waterproof and holds no protection 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.
- Avoid using Mallya near PACEMAKERS and DEFIBRILLATORS.
- Mallya contains a magnet, avoid contact with metallic parts during use.
- Do not disassemble, modify or repair the instrument by yourself. Refer all servicing to the
BIOCORP PRODUCTION authorized dealer.
- Do not expose the device to temperatures above 40°C (104°F) or flames.
- Never try to access the internal hardware of your device.
- 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 sharp edges that
may cause injuries or that may detach and create a choking hazard.
- Mallya must only be paired with a compatible mobile application.
- Mallya has been designed to work with ONE insulin pen. If you unpair your Mallya base
from the insulin pen, you MUST reselect your insulin pen medication.
- Never install a mobile application from unofficial stores on your phone.
- Jailbreak or rooted phone exposes it to dangers and will invalidate the Mallya warranty.
CAUTION: improper operation may result in bodily injury or property damage
- The Instructions for Use should be accessible to you at all times and you should consider
all instructions carefully before using the device.
- Mallya is intended for Over the Counter use and is not a prescription device.
- Protect your personal health data by using a password on your smartphone (protection with
the phone password).
- Do not wipe the surface of Mallya with chemical products or solvents (e.g. acetone) (other
than those specified in the cleaning procedure – see step 10.3.) as it could lead to
discoloration or deterioration.
- 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.
- 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. Other cables may create problems or
interfere with other electronic devices.
Before disposing of Mallya: reset the device to delete all your personal health data (see step
9.3.)

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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.
- The user that changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
- This device complies with FCC radiation exposure limits set forth for general population.
This device must not be co-located or operating in conjunction with any other antenna or
transmitter.
NOTE:
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance with
the instruction, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception which can be determined by turning
the equipment off and on, the user is encouraged to try to correct interference by one or more
of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on circuit different from that to which the receiver is
connected.
- Consult the dealer or an experienced radio/TV technician for help.

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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 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.
0.2 INTENDED USE
Indications for use:
Mallya can be used either for type I or type II diabetes.
The device is intended to assist patients maintain accurate records of their insulin usage.
WARNING
The device should not be used by children and women with gestational diabetes.
Contraindications:
There are no known contraindications to the use of Mallya.
Intended Patient population:
Intended users are patients and medical professionals.
Mallya can only be used by patients already familiar with the pen injectors: Kwikpen
®
(Eli
Lilly), Solostar
®
(Sanofi) or Flexpen
®
(Novo Nordisk).
Over the Counter (OTC) Medical Device:
Mallya is intended for Over the Counter use and is not a prescription device.
Sterility information:
Mallya is intended to be non-sterile.
Adverse reaction information:
There are no known adverse reactions to the use of Mallya.
Intended use location:
The device is intended for use in a medical office or at home.
Mallya
base
Mallya
knob

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1. MALLYA COMPATIBILITIES WITH PENS
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 2 - Mallya compatibilities – Molecules and concentrations

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2. GETTING TO KNOW YOUR MALLYA DEVICE
2.1 GETTING STARTED
The shipment box contains the following items. The Part Numbers (PN) vary depending on
the Mallya model (Mallya designed for FLEXPEN or KWIKPEN or SOLOSTAR):
Mallya DEVICE:
1 X Mallya BASE
Applied part
For the insulin pen FLEXPEN
®
NOVO NORDISK:
PN: 0273778
For the insulin pen KWIKPEN
®
ELI LILLY:
PN: 0273694
For the insulin pen SOLOSTAR
®
SANOFI:
PN:
0273777
2 X
Mallya
KNOB
S
Applied part
For the insulin pen FLEXPEN
®
NOVO NORDISK:
PN : 0273727
Applied part
For the insulin pen KWIKPEN
®
ELI LILLY:
PN : 0273698
Applied part
For the insulin pen SOLOSTAR
®
SANOFI:
PN: 0273710
Mallya ACCESSORIES:
1 x USB CABLE
1 x RESET KEY
1 x QUICK START GUIDE
Quick Start Guide
with reference: QSG_MAL_US
CAUTION
Consult the Instructions For
Use documents:
Reference: IFU_MAL_US
Part Number: B014JOOZFS
Model: B004OQOQQ0
Manufacturer:
Bright Sea Industrial. Co
Table 3 - Mallya box contents
NOTE :
Before you use your Mallya for the first time, you have to charge it. Use the provided USB
cable to connect the Mallya base to a USB port or outlet. Let it charge for at least 10 minutes.

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2.2 FEATURES OF YOUR MALLYA
2.3 WEIGHT AND SIZE OF THE MAIN ELEMENTS
Element
Weight
Size
Mallya base 0.016 kg
KWIKPEN
®
base:
(60.8x28.9x21.3) mm
FLEXPEN
®
and SOLOSTAR
®
bases:
(60.8x26.9x21.3) mm
Mallya knob 0.006 kg
KWIKPEN
®
knob
:
(11.6 x Ø22) mm
SOLOSTAR
®
knob
:
(24.4 x Ø20) mm
FLEXPEN
®
knob
:
(26.3 x Ø19.3) mm
Mallya
total weight
0.022 kg
Table 4 - Weight and size of the main elements
2.4 STORAGE INFORMATION
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%
Operating +15°C to +35°C
(59°F < T° < 95°F) 800 hPa to 1060 hPa 30% to 70%
Table 5 - Storage information
LED
Clear square
dose window
Micro
USB port
Knob