FLAEM Aspira 11 Manual De Instrucciones página 18

NOTIFICATION OF SERIOUS EVENTS
Serious events occurring in connection with this product must be reported immediately to the manufacturer 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
Ireland
Malta
SYMBOLS ON DEVICE OR PACKAGING
Medical CE marking ref. regulation 2017/745 EU and
subsequent updates
Class II device
Before use: Caution check instructions for use
Switched
'ON'
When switching off the unit, the switch stops
compressor operation on only one of the two
power phases.
Switched
'OFF'
Attention
Model number
Temperature limits
Atmospheric pressure limits
Batch Code
+
Greater vacuum
-
Less vacuum
Quality mark
AUTHORITY
Health Products Regulatory Authority
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
San Ġwann SĠN 3000
E-mail : devices.medicinesauthority@gov.mt
18
Serial number of the device
Manufacturer
Type BF applied part
Protection rating of the envelope: IP21.
IP21
(Protected against solid bodies larger than 12 mm.
Protected against access with a finger; Protected
against vertically falling drops of water).
Alternating current
See instructions for use
Medical device
Moisture limits
Production date
Unique device identifier
Single use