BIOCORP Mallya User manual

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Quick Start Guide
TURN YOUR INSULIN PEN INTO A SMART DEVICE

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Mallya captures insulin injection data and sends the information to a compatible
mobile app by Bluetooth.
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 dose selected for injection (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 application on a Bluetooth paired smartphone.
INTENDED USE
Mallya aims to help patients keep accurate records of their insulin injections.
Mallya can be used without any connection to a mobile application (in which case,
injection data are not recorded and cannot be shared) or it can be connected to
a mobile application.

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Warnings: improper operation may result in serious injury or death
- Disconnect Mallya from the USB power cable before using Mallya.
- Mallya is not waterproof and holds no protection against the inltration of water or
moisture:
Do not immerse the device in water or 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 device by yourself.
- All repairs should be carried out by the dealer authorised by BIOCORP PRODUCTION,
whose information is given on the packaging.
- Do not expose the device to a temperature above 40°C (104°F) or flames.
Cautions: improper operation may result in bodily injury or property damage
- Please consider all instructions carefully before using the device.
- Protect your personal health data by using a password on your smartphone.
- Do not wipe the exterior of Mallya with chemical products or solvent (e.g. acetone) as
it may lead to discoloration or deterioration.
- If the device has been subjected to an external mechanical shock (knocking,
shocking, falling, etc.), this may cause a malfunction. In such case, please contact a
dealer authorised by BIOCORP PRODUCTION for technical assistance.
- Mallya is supplied with a USB cable. Do not use any other cable. Use the cable
supplied with the device to connect it to the USB power port.
* READ THE INSTRUCTIONS FOR USE (AVAILABLE ONLINE AT MY-MALLYA.COM)
TO ACCESS COMPLETE LIST OF WARNINGS AND CAUTIONS

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* READ THE INSTRUCTIONS FOR USE (AVAILABLE ONLINE AT MY-MALLYA.COM)
TO ACCESS COMPLETE LIST OF WARNINGS AND CAUTIONS > DOWNLOAD A COMPATIBLE APP
Mallya connects your insulin
pen to your smartphone.
Use a compatible application
to keep track of your insulin
injections.
Download the application from:
Apple
Store
Play
Store
STEP 1

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Notes:
- Packaging contains 2 buttons (1
being a spare).
- The reset key ( ) is not needed
for setup.
> UNPACK EQUIPMENT
STEP 2
1x
USB
CABLE
2x
ou
MALLYA
BUTTON
1x
MALLYA
BASE
1x
RESET
KEY

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> CHARGE THE BASE
STEP 3
Using the supplied USB cable, connect the Mallya base to a USB
port or socket. Leave the device charging for at least 10 minutes
and then go to step 4.
The Mallya LED slowly flashes
green when the base is being
charged.
Note:
Optimum autonomy is reached after approximately 2 hours of
charging.

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> UNPLUG AND CALIBRATE MALLYA BASE
STEP 4
If the LED flashes
orange, slowly tilt the
base from side to side
to CALIBRATE.
Continue tilting until:
The base beeps
and the LED turns
green.
Then the
LED turns
off.
Disconnect Mallya base
from the USB cable.
If no light appears after unplugging
the base, go directly to step 5.

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STEP 5> MOUNT MALLYA BASE ONTO THE PEN
5.1 - Hold Mallya base so
that the clear square plastic
window is facing you.
5.2 - Align the base dose window
with the pen dose window then
clip the base onto the pen.
5.3 - Make sure Mallya dose
window is well aligned with the
pen dose window.

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STEP 6> MOUNT MALLYA BUTTON ONTO THE PEN
Place the Mallya button over
the pen button, then push
down.
Mallya LED flashes orange and green
when base and button are properly
mounted onto the pen.
Note - LED remaining orange may indicate that:
Dose windows are not
properly aligned.
Mallya button is not
pushed enough.
Proper
alignment.

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STEP 7> PAIR MALLYA WITH YOUR SMARTPHONE
A - Make sure that Mallya is within
12 inches of your smartphone.
B - Open the application and follow
the instructions for pairing.
When Mallya LED turns green,
pairing is done and your insulin pen
is ready for use:

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TRANSFERRING MALLYA TO A NEW PEN
A - Holding the pen tightly with one hand, remove the base with the
other hand.
B - Remove the Mallya button from the pen button.
C - Follow steps 5 and 6 to mount
base and button onto your new
insulin pen.
Mallya base and button are only compatible with disposable
insulin pens of the selected model (Solostar – Kwikpen –
Flexpen).
Do not mount, pair or use your Mallya with another insulin pen
model.

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Red (solid)
Green (slow flashing)
Green (solid)
Orange
(rapid flashing)
Orange (flashing
every 15 seconds)
Mallya is on charge (see step 3).
- Remove Mallya from the pen and re-
calibrate (step 4),
- If the problem persists, reset Mallya
(please read the instructions for use),
- If the problem is not solved, contact
Mallya authorised dealer service line.
Mallya is properly mounted on the pen
(see step 7).
Orange (solid)
Calibration is in progress (see step 4).
Battery is low. Put Mallya on charge (see
step 3).
Position error: make sure that the pen dose dial is set
to “0”.
Mounting error: check that Mallya base and button are
properly mounted on your pen (see steps 5 and 6).
Alternative Orange
and green
Rapid flashing
Pair Mallya with your smartphone (see
step 7).
DESCRIPTION OF LED SIGNALS

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Instructions for use are available on my-mallya.com website.
All illustrations in this guide are based on a Mallya for Solostar.
However, all the steps described above can be transposed identi-
cally, regardless of the model of your Mallya (Kwikpen - Solostar
- Flexpen).
EU Simplied Conformity Declaration
The undersigned BIOCORP PRODUCTION declares that the radio
equipment of the Mallya type complies with Directive 2014/53/EU.
The full text of the EU Declaration of Conformity is available at
the following internet address: my-mallya.com

PT Lavaur La Bechade
63500 Issoire
FRANCE
www.biocorp.fr