8
SYMBOLS
Certification TÜV
CE Medical Marking ref. Dir. 93/42
EEC and subsequent amendments
Serial number of device
Class II device
Manufacturer
Important: check the operating
instructions
Type BF applied part
“OFF” for part of equipment
Alternating current
“ON” for part of equipment
Hazard: electrocution.
Consequence: Death.
Do not use device while taking a bath
or shower
Complies with: European standard
EN 10993-1 “Biological Evaluation
of Medical Devices” and European
Directive 93/42/EEC “Medical
Devices”. Phthalates free. In
conformity with Reg. (EC) no.
1907/2006
IP21
Enclosure protection rating: IP21.
(Protected against solid bodies over
12 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
ELECTROMAGNETIC COMPATIBILITY
This device was designed to satisfy the currently required requisites for electromagnetic
compatibility (EN 60601-1-2:2015). 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. 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. The Medical Device may be subject to electromagnetic interference
if other devices are used for specific diagnosis or treatments. Flaem reserves the right to
make technical and functional modifications to the product with no prior warning.
