Spare Parts; Device Disposal; Electromagnetic Compatibility - FLAEM Aspira Instrucciones Para El Uso

SPARE PARTS

Description
DURABLE CANISTER (STERILISABLE) complete with tubing and filter
SINGLE PATIENT USE CANISTER complete with tubing and filter

DEVICE DISPOSAL

In compliance with the Directive 2012/19/CE, the symbol printed on the device shows that the device to be
disposed of is considered waste and must therefore be an item of "differentiated collection". Consequently,
the user must take it (or have it taken) to the differentiated collection sites provided by the local authorities,
or turn it in to the dealer when purchasing an equivalent new device. Differentiated waste collection and
the subsequent treatment, recycling and disposal procedures promote the production of devices made with
recycled materials and limit the negative effects on the environment and on health caused by potential improper
waste management. The unlawful disposal of the product by the user could result in administrative fines as
provided by the laws transposing Directive 2012/19/EC of the European member state or of the country in which
the product is disposed of.

ELECTROMAGNETIC COMPATIBILITY

This device was designed to satisfy the current requirements for electromagnetic compatibility (EN 60 601-1-2). 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. There is a risk of potential
electromagnetic interference with other devices, in particular with other analysis and treatment devices. RF mobile or
portable radio and telecommunications devices (mobile telephones or wireless connections) might interfere with the
operation 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.
SYMBOLS
Class II device
Type BF applied part
Attention: check the instruc-
tions for use
Single use
Alternating current
Ethylene oxide sterilisation
Expiry date
Device serial number
TÜV Certification
Minimum and maximum
room temperature
Minimum and maximum
atmospheric pressure
Minimum and maximum air
moisture
Without latex
Protection rating of the cas-
ing: IP21.
(Protected against solid
IP21
foreign objects larger than
12mm. Protected against ac-
cess with a finger; Protected
against vertically dripping
water).
17
Code
ACO728P
ACO727P
When
"ON"
switched off, the on/off
switch stops compressor
function in only one phase
of the two-phase power
"OFF"
supply.
EC Marking medical ref. Dir. 93/42 EEC and
0051
subsequent updates
Production year
Manufacturer
Risk: electrocution.
Consequence: Death.
Do not use the device
while taking a bath or a shower
the device is