IFU_MAL_US_V1.13_January 2021
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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