BIOCORP Mallya - 3 Device Description and Exam Environment; Device Description; Mallya Characteristics; Essential Performances of the System (Significant Operating Characteristics)

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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