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NOTICE (ref. A Directive 2007/47/EC)
Flaem Nuova SpA has been manufacturing top-quality electro-medical appliances for the
past 50 years or more, using carefully selected and tested materials in compliance with the
requirements of reference directives and standards, with patient/user safety as number
one priority. Because of this, we are able to state that the use of the Flaem device and
original accessories purchased by you does not involve any risk whatsoever for the user’s
health.
The specific tests conducted at accredited laboratories (as per UNI EN ISO 10993-17:
2004 rule on Biological Assessment Part 17 Definition of allowable limits for leachable
substances) actually demonstrate that the BPA used is released in amounts much lower
than the maximum allowed for the safety threshold.
SYMBOLS
NEBULISER
CE Medical Marking ref. Dir.
93/42 EEC and subsequent
amendments. In compliance
with EN 60601-1-11
Serial number of the device
Class II unit
Manufacturer
Important: check the operating
instructions
BF-type fixed part
In compliance with European
standard EN 10993-1 Biological
evaluation of medical devices
and 93/42/EEC Medical Devices
Directive”
Protect the device against
moisture
Minimum and maximum room
temperature
Minimum and maximum air moisture
Minimum and maximum
atmospheric pressure
Hazard: electrocution.
Consequence: Death.
Do not use the unit while bathing
or showering.
Direct current
POWER SUPPLY UNIT
Compliant with Directives
Plug for very low safety voltage
Power supply unit for home use
