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Beschikbare talen
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CE Medical Marking ref. Dir. 93/42
EEC and subsequent amendments
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). 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. 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.
PACKAGING DISPOSAL
Product box
20
PAP
Heat shrink film accessories
05
PP
Certification TÜV
Serial number of device
Manufacturer
Type BF applied part
Alternating current
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
Product packaging bag and Tube
04
packaging bag
LDPE
8
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