7
ENGLISH
• The devices are not intended to be used in
hazardous areas/in the MRI environment.
Health risks associated with handling infec-
tious agents or pathogens
Infectious agents and pathogens in the aspi-
rate cause health risks.
• Never operate the device without an exter-
nal bacterial filter.
(exception: ASSKEA disposable secretion
canister system)
• Check that the external bacterial filter is dry
and clean prior to each use to ensure fault-
less function! (exception: ASSKEA dispos-
able secretion canister system)
• Always perform the aspiration using a suit-
able sterile disposable catheter. The suction
tube must never come into direct contact
with the aspiration site.
• Follow the hygiene, cleaning and decon-
tamination instructions (see section 4).
Risk of strangulation
• People may strangle themselves on the
tubing or the mains cable, especially if
tubes resp. cables are unduly long.
• Ensure that no unauthorized/uninvolved
persons are near the device during aspira-
tion.
• Store the device incl. accessories in the
shipping carton until the next time of use.
Damage to the device due to heat build up
• Do not cover the power supply unit.
• Keep the aspirator as well as the mains ca-
ble and the power supply unit away from
other heat sources.
• Do not place the aspirator directly adjacent
to other devices, since this can result in sig-
nificant warming of the aspirator.
Safety defects due to incorrect accessories
and spare parts
The use of accessories and spare parts, de-
tachable parts or materials that are not rec-
ommended by ASSKEA GmbH and specified
in the instruction for use may compromise
the safety and function of the device. Any
warranty is excluded for damage caused by
using accessories and spare parts not recom-
mended or by improper use.
Use only the recommended original accesso-
ries and spare parts.
Damage to the device due to improper
handling
• Never aspirate flammable, corrosive or ex-
plosive liquids or gases.
• Do not drop the device.
• Prior to each use, check the housing for any
damage and do not operate the device if
there is obvious damage to the housing.
• Prior to each use, check the suction tube,
secretion canister, bacterial filter and, if ap-
plicable, any other accessories that are sub-
ject to wear and damage, to ensure that the
components are in perfect condition and
proper operation of the device is guaran-
teed. If this is not the case, replace the parts
immediately.
Risks to people due to improper handling
• Use the device only for its intended pur-
pose.
• Never use the device for aspiration in the
low vacuum range (e.g. thoracic drainage).
• If aspiration procedures are carried out too
often, slight bleeding may occur.
• When using the power supply unit, ensure
that it is connected to the aspirator first and
then to the mains supply (100 V to 240 V AC).
Disconnection of the power supply unit
from the mains supply must be performed
in exactly the opposite sequence (first re-
move the power supply unit from the mains
supply (100 V to 240 V AC) and then remove
it from the aspirator).
• When using the mains cable, ensure that it
is connected to the aspirator first and then
to the mains supply (230 V). Disconnection
of the mains cable must be performed in
the opposite sequence.
• Never touch parts of non-ME devices in the
patient enviroment and the patient simulta-
neously.