SYMBOLS
CE Medical Marking ref. Dir. 93/42
EEC and subsequent amend-
ments
Class II device
Important: check the operating
instructions
"OFF" for part of equipment
"ON" for part of equipment
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
Minimum and maximum room
temperature
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.
Certification TÜV
Serial number of device
Manufacturer
Type BF applied part
Alternating current
Hazard: electrocution.
Consequence: Death.
Do not use device while taking a
bath or shower
Enclosure protection rating: IP21.
(Protected against solid bodies over
IP21
12 mm. Protected against access
with a finger;
Protected against vertically falling
water drops.)
Minimum and maximum air moisture
15