Use Instructions

Page 4 / 27 IFU_EMB_AD_US-CA-EN_V2
3. DEVICE DESCRIPTION AND EXAM ENVIRONMENT
3.1 DEVICE DESCRIPTION
EMBODY CHARACTERISTICS
The EMBODY device is composed of a base and a button:
BASE
BUTTON
ESSENTIAL PERFORMANCES OF THE SYSTEM (SIGNIFICANT
OPERATING CHARACTERISTICS)
The essential performance characteristic for the EMBODY 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
A compatible mobile application allows the patient to securely display treatment information.
This improves the patient’s therapeutic adherence.
EMBODY PARTS REFERENCES
The references (Part Numbers) vary depending on the EMBODY model:
EMBODY MODEL
EMBODY BASE
APPLIED PART
EMBODY BUTTON
APPLIED PART
EMBODY designed for
SOLOSTAR
®
SANOFI insulin
pen
PN : 02737
90
PN:
0273710
Table 4 - EMBODY parts numbers
Micro
USB port
Clear square
dose window
LED
Button