• Risk of electrocution:
- Before first use, and periodically during the life of the product, check the integrity of the structure of the appliance supplied and
the power cord to ensure that there is no damage; if it is damaged, do not plug it in and immediately take the product to an
authorised service centre or your dealer.
- Do not carry out any hygienic preparation when the device is in use on a patient.
- In the presence of children and care-dependent persons, the appliance must be used under the close supervision of an adult who
has read these operating instructions.
- Keep the power cable away from animals (e.g. rodents), otherwise such animals could damage the insulation of the power cable.
- Always keep the power cable away from hot surfaces.
- Do not immerse the appliance in water; if this happens, pull the plug immediately. Do not pull out or touch the appliance while
immersed in water, unplug it first. Take it immediately to an authorised FLAEM service centre or your dealer.
- Do not wash the appliance under running water or by immersion and keep it away from splashes of water or other liquids.
- The device is equipped with a safety fuse that can be easily inspected in the event of a fault. Before doing so, remove the power
supply plug.
- The supplied cable is fitted with a protective seal (17a) against the penetration of liquids into the device. Do not separate this seal
from the cable.
• Risk of ineffectiveness of therapy:
- Only use original Flaem accessories or spare parts, no liability is accepted if non-original parts or accessories are used.
- The device is not suitable for use in MRI (Magnetic Resonance Imaging) environments
- Ensure that the connections and closing of the collection vessel are carried out carefully to avoid aspiration leaks.
- With the intervention of the protection device (10) aspiration ceases, switch off the appliance, empty the vessel (8/9) and carry
out hygienic preparation.
• Risk of infection :
- Personal use of the accessories, collection vessels and connecting tubes is recommended to avoid risks of infection.
- The manual aspirated flow control (15) is a sterile disposable product and must be replaced each time it is used.
- Check the expiry date on the original packaging of the manual aspirated flow control (15) or on the label on the packaging of
the device and check the integrity of the sterile packaging, if the packaging is not intact please contact your Flaem authorised
service centre or your dealer. FLAEM NUOVA will not be held liable for damage to the patient related to the deterioration of the
above-mentioned sterile packaging due to manipulations carried out by third parties on the original packaging of the entire
device.
- The hydrophobic/antiviral and antibacterial filter supplied with Flaem equipment is a disposable device and must be replaced
after each use and if the filter becomes saturated.
Check the expiry date on the original filter packaging or on the label on the aspirator packaging.
- Follow hygienic preparation before each use.
- Do not tip the vessel while it is connected to the aspirator in operation, as liquid can be sucked into the aspirator and thus dam-
age the pump. If this happens, switch the aspirator off immediately and empty and clean the vessel (send it to an authorised
FLAEM service centre).
• Risk of injury:
- Do not place the medical device on a soft supporting surface such as a sofa, a bed or a tablecloth.
- Always operate it on a hard surface clear of any objects.
WARNINGS ON INTERFERENCE RISKS DURING USE IN DIAGNOSTIC INVESTIGATIONS
• This device is designed to meet the current requirements for electromagnetic compatibility. As far as EMC requirements are concerned,
electromedical devices require special care when being installed and used, and are therefore required to be installed and/or used
in accordance with 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
electromedical devices. The device may be susceptible to electromagnetic interference in the presence of other devices used for
specific diagnosis or treatment. For more information visit www.flaemnuova.it.
• The Medical device is not suitable for use in MRI (Magnetic Resonance Imaging) environments.
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