IFU_MAL_EN_V6
TABLE OF CONTENTS
1. GENERAL INFORMATION .............................................................................................................2
2. MALLYA COMPATIBILITIES – MOLECULES AND CONCENTRATIONS...................................2
3. DEVICE DESCRIPTION AND EXAM ENVIRONMENT..................................................................3
3.1 DEVICE DESCRIPTION .........................................................................................................3
3.1.1 MALLYA CHARACTERISTICS...........................................................................................3
3.1.2 ESSENTIAL PERFORMANCES OF THE SYSTEM (SIGNIFICANT OPERATING
CHARACTERISTICS)......................................................................................................................3
3.1.3 MALLYA PARTS REFERENCES .......................................................................................3
3.2 WEIGHT AND SIZE OF THE MAIN ELEMENTS ...................................................................4
4. SAFETY INFORMATION ................................................................................................................4
4.1 SYMBOLS ON THE DEVICE AND ITS PACKAGING ............................................................4
4.2 WARNINGS AND CAUTIONS ................................................................................................5
4.3 ELECTRICAL SAFETY ...........................................................................................................6
4.4 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS ..................7
4.5 MALLYA BASE LABELING.....................................................................................................7
4.6 TRANSPORT AND STORAGE CONDITIONS .......................................................................8
4.7 USAGE CONDITIONS ............................................................................................................8
4.8 DISPOSAL ..............................................................................................................................8
5. UNPACKING AND INSTALLING MALLYA (CHARGING / CALIBRATING / ASSEMBLING /
PAIRING)..................................................................................................................................................9
5.1 UNPACKING YOUR MALLYA AND ITS ACCESSORIES......................................................9
5.1.1 PACKAGE CONTENTS......................................................................................................9
5.1.2 UNPACKING.......................................................................................................................9
5.2 CHARGING AND CALIBRATING YOUR MALLYA ............................................................. 10
5.2.1 CHARGING YOUR MALLYA........................................................................................... 10
5.2.2 CALIBRATING YOUR MALLYA ...................................................................................... 11
5.3 ASSEMBLING YOUR MALLYA TO THE INSULIN PEN ..................................................... 12
5.3.1 ATTACHING BASE TO PEN ........................................................................................... 12
5.3.2 ATTACHING BUTTON TO PEN...................................................................................... 12
5.4 PAIRING MALLYA WITH YOUR SMARTPHONE ............................................................... 13
5.4.1 INSTALLING THE MALLYA MOBILE APPLICATION..................................................... 13
TECHNICAL COMPATIBILITIES ................................................................................ 13
DOWNLOAD THE MALLYA APPLICATION AND GET STARTED ............................ 13
5.4.2 PAIRING .......................................................................................................................... 13
6. OPERATING INSTRUCTIONS .................................................................................................... 17
6.1 SECURITY TEST - PRIMING .............................................................................................. 17
6.2 INJECTION .......................................................................................................................... 18
7. MANAGE RECORDED DATA ..................................................................................................... 19
7.1 DISPLAY OF THE RECORDED DATA ............................................................................... 19
7.2 MANAGE YOUR RECORDED DATA .................................................................................. 20
7.2.1 YOU CAN CHANGE A “PRIMING” OR A “DOSE” QUANTITY ....................................... 20
7.2.2 YOU CAN CHANGE AN INJECTION RECORDED AS A “DOSE” TO A “PRIMING”, OR A
“PRIMING” TO A “DOSE” ............................................................................................................. 20
7.2.3 YOU CAN DELETE A “DOSE” OR A “PRIMING”............................................................ 21
7.2.4 YOU CAN ADD AN INJECTION THAT WAS NOT RECORDED TO THE HISTORY .... 21
7.2.5 YOU CAN FILL IN A DOSE THAT WAS NOT CAPTURED BY THE DEVICE ............... 22
7.3 OTHER FEATURES OF THE MALLYA APPLICATION ...................................................... 22
7.3.1 GENERATE A REPORT.................................................................................................. 22
7.3.2 PAIR TWO MALLYA DEVICES TO YOUR MOBILE APPLICATION.............................. 23
7.3.3 SETTINGS ....................................................................................................................... 24
7.3.4 “HELP” SCREEN ............................................................................................................. 26
