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BIOCORP Mallya - Page 5

BIOCORP Mallya
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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: gdpr@biocorp.fr
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

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