Use Instructions

IFU_EMB_AD_US-CA-EN_V2
TABLE OF CONTENTS
1. GENERAL INFORMATION ...........................................................................................................3
2. EMBODY COMPATIBILITIES – MOLECULES AND CONCENTRATIONS ................................3
3. DEVICE DESCRIPTION AND EXAM ENVIRONMENT ................................................................4
3.1 DEVICE DESCRIPTION ......................................................................................................4
EMBODY CHARACTERISTICS ...................................................................................4
ESSENTIAL PERFORMANCES OF THE SYSTEM (SIGNIFICANT OPERATING
CHARACTERISTICS) ...............................................................................................................4
EMBODY PARTS REFERENCES ...............................................................................4
3.2 WEIGHT AND SIZE OF THE MAIN ELEMENTS ................................................................5
4. SAFETY INFORMATION ................................................................................................................5
4.1 SYMBOLS ON THE DEVICE AND / OR ITS PACKAGING ...............................................5
4.2 WARNINGS AND CAUTIONS ............................................................................................6
4.3 ELECTRICAL SAFETY .......................................................................................................7
4.4 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS .............8
4.5 EMBODY BASE AND BUTTON LABELING ......................................................................8
4.6 TRANSPORT AND STORAGE CONDITIONS ...................................................................9
4.7 USAGE CONDITIONS .........................................................................................................9
4.8 DISPOSAL ...........................................................................................................................9
5. UNPACKING AND INSTALLING EMBODY (CHARGING / CALIBRATING / ASSEMBLING /
PAIRING) ............................................................................................................................................... 10
5.1 UNPACKING YOUR EMBODY AND ITS ACCESSORIES ............................................. 10
5.2 CHARGING AND CALIBRATING YOUR EMBODY ....................................................... 11
5.3 ASSEMBLING YOUR EMBODY TO THE INSULIN PEN................................................ 13
5.4 OPERATING IN AUTONOMOUS MODE OR IN PAIRING MODE .................................. 14
6. OPERATING INSTRUCTIONS ................................................................................................... 15
6.1 SECURITY TEST - PRIMING ........................................................................................... 15
6.2 INJECTION ....................................................................................................................... 16
7. AFTER USE INSTRUCTIONS: DISASSEMBLE EMBODY FROM PEN .................................... 17
8. TROUBLESHOOTING ................................................................................................................. 18
8.1 TROUBLESHOOTING EMBODY: VISUAL AND AUDITIVE BASE SIGNALS .............. 18
8.2 RESET INSTRUCTIONS .................................................................................................. 20
9. MAINTENANCE AND INSPECTION .......................................................................................... 20
9.1 EMBODY DEVICE LIFETIME .......................................................................................... 20
9.2 CLEANING YOUR EMBODY ........................................................................................... 20
9.3 MAINTAIN WATER, DUST AND LIGHT RESISTANCE ................................................. 21
10. TECHNICAL SPECIFICATIONS & PERFORMANCE ............................................................... 22
10.1 ELECTRICAL RATINGS .................................................................................................. 22
10.2 MATERIALS ..................................................................................................................... 22
10.3 ACCURACY ...................................................................................................................... 22
11. ELECTROMAGNETIC COMPATIBILITY ................................................................................... 23
11.1 GENERAL PRECAUTIONS AND WARNINGS ............................................................... 23
11.2 ELECTROMAGNETIC EMISSIONS ................................................................................. 23
11.3 INTERFERENCE IMMUNITY ........................................................................................... 24
11.4 ELECTROMAGNETIC IMMUNITY ................................................................................... 26
12. DISCLAIMER .............................................................................................................................. 27