FLAEM NUOVA P0709EM Notice D'utilisation page 15

Batteries:
The depleted batteries must be disposed of in the appropriate collection containers.
NOTIFICATION OF SERIOUS EVENTS
Serious events occurring in connection with this product must be reported immediately to the manu-
facturer or the competent authority.
An event is considered serious if it causes or may cause, directly or indirectly, death or an unforeseen
serious deterioration in a person's state of health.
COUNTRY AUTHORITY
Health Products Regulatory Authority
Ireland Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: devicesafety@hpra.ie
Medical Devices Unit Medicines Authority
Sir Temi Żammit Buildings, Malta Life Sciences Park
Malta
San Ġwann SĠN 3000
E-mail : devices.medicinesauthority@gov.mt
SYMBOLS ON DEVICE OR PACKAGING
Medical CE marking ref. regulation
2017/745 EU and subsequent updates
Batteries
Before use: Caution check instructions
for use
Phthalate- and bisphenol-free
Model number
Temperature limits
Atmospheric pressure limits
Moisture limits
Quality mark
Serial number of the device
Manufacturer
Type BF applied part
Attention
Protected against solid foreign bodies of
IP45
Ø 1 mm or larger and against water jets
Medical device
Unique device identifier
Production date
15