12
13
SYMBOLS
TUV approval ref. EN 60601-1 3rd Ed. - EN 60601-1-11
EC Marking medical ref. Dir
93/42 EEC and subsequent
updates
Device serial number
Class II device
Manufacturer
Attention: check the instruc-
tions for use
Type BF applied part
“OFF” for part of equipment
“ON” for part of equipment
Alternating current
Risk: electrocution.
Consequence: Death.
Using the device while taking a
bath or shower is prohibited
In compliance with: European
Standard EN 10993-1 ‘’Biologi-
cal Evaluation of medical de-
vices’’ and European Directive
93/42/EEC “Medical Devices.”
Phthalate-free. In compliance
with: Reg. (EC) no. 1907/2006
IP21
Degree of protection of the cas-
ing: IP21.
(Protected against solid foreign objects
larger than 12mm. Protected against access
with a finger; Protected against vertically
dripping water).
Minimum and maximum
ambient temperature
Minimum and maximum humid-
ity
Minimum and maximum air
pressure
ELECTROMAGNETIC COMPATIBILITY
This device was designed to satisfy the currently required requisites for
electromagnetic compatibility (EN 60601-1-2:2007). Electro-medical devices require
particular care during installation and use relative to EMC requirements. Users are
therefore requested to install and/or use these devices following the manufacturer’s
specifications. There is a risk of potential electromagnetic interference with other
devices, in particular with other analysis and treatment devices. RF mobile or portable
radio and telecommunications devices (mobile telephones or wireless connections)
can interfere with the functioning of electro-medical devices. For further information
visit our website www.flaemnuova.it. Flaem reserves the right to make technical and
functional modifications to the product with no prior warning.
