1
5
SYM
B
OLS
C
ertification TÜV
C
E Medical Marking ref
.
Dir
.
9
3
/
42
EE
C
and subsequent
amendments
Serial number of device
C
lass II device
Manufacturer
Important: check the operating
instructions
Type BF applied part
“OFF” for part of equipment
A
lternating current
“ON” for part of equipment
C
omplies with: European
standard EN 1099
3
-1 “Biological
Evaluation of Medical Devices”
and European Directive
9
3
/
42
/EE
C
“Medical Devices”
.
Phthalates free
.
In conformity
with Reg
.
(E
C
) no
.
1907/
2
00
6
IP21
Enclosure protection rating: IP
2
1
.
(Protected against solid bodies over 1
2
mm
.
Protected against access with a finger;
Protected against vertically falling water
drops)
.
Minimum and maximum room
temperature
Minimum and maximum air moisture
Minimum and maximum
atmospheric pressure
ELE
C
TROM
A
GNETI
C
C
OMP
A
TI
B
ILITY
This device was designed to satisfy the currently required requisites for electromagnetic
compatibility (EN
6
0
6
01-1-
2
)
.
Electro-medical devices require particular care during
installation and use relative to EM
C
requirements
.
Users are therefore requested to install
and/or use these devices following the manufacturer's specifications
.
Risk of potential
electromagnetic interference with other devices
.
Mobile or portable RF radio and
telecommunication devices (mobile phones or wireless connections) may interfere with
the operation of medical devices
.
For more information, visit the website www
.
flaemnuova
.
it
.
The appliance may be susceptible to electromagnetic interference in the presence of
other devices used for specific diagnoses or treatments
.
Flaem reserves the right to make
technical and functional changes to the product without prior notice
.
