Air Filter - FLAEM RespirAir Mode D'emploi

Accessories C1.1-C1.2-C1.3-C1.4-C2-C3-C4 can be sterilised.
Device: Fractionated vacuum overpressure steam steriliser in accordance with EN 13060.
Implementation: Wrap every single part to be treated with a sterile barrier system or
packaging in accordance with Norm EN 11607. Place the packed components in the steam
steriliser. Run the sterilisation cycle according to the operating instructions of the device by
selecting a temperature of 134°C and a time of 10 minutes first.
Storage: Store the sterilised parts as per the instructions for use of either the sterile barrier
system or packaging.
The sterilisation procedure is validated in its conformity to ISO 17665-1.

AIR FILTER

The device has a suction filter (A3) that should be replaced when it is
dirty or changes color. Do not wash or reuse the same filter. Regular
replacement of the filter is required to help and ensure correct
performance of the compressor. Check the filter on a regular basis.
Contact your local dealer or authorized service center for spare filters.
Use original FLAEM accessories only.
SYMBOLS
TÜV Certification ref. EN 60601-1 3° Ed. EN60601-1-11
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"
Phthalate-free. In compliance
with: Reg. (EC) no. 1907/2006
Serial number of device
Manufacturer
Type BF applied part
Alternating current
Hazard: electrocution.
Consequence: Death. Do not use de-
vice 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).
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