Operation; Important Warnings - FLAEM Pulmowaves P0112EM F1000 Gebrauchs- Und Wartungsanleitung

FUNCTIONS OF THE MEDICAL DEVICE
The medical device has the following functions:
• PEP system (Positive Expiratory Pressure), which removes phlegm.
• Vibrations of the inhaled air that removes and loosens secretions.
• Aerosol therapy to humidify and treat the respiratory tract.

OPERATION

The operation is based on the generation of vibrations by the pneumatic compressor that is automatically
activated by the inhalation of the patient. These vibrations, whose amplitude is adjustable via the flow regu-
lator on the device console, enables the removal of mucus that clogs the airways. To avoid drying the airway
during the treatment, the flow inhaled by the patient draws the aerosol of the saline solution, produced by the
ultrasonic nebuliser.
During the treatment, the presence of a 5-position adjustable PEP device allows for the management of the
exhalation phase of the patient, the flow intensity of which is approximately visible by the pressure gauge
located in the central area of the console.

IMPORTANT WARNINGS

The manufacturer makes every effort to ensure that every product is of the highest quality and safety; how-
ever, as for any electrical device, basic safety regulations must always be followed in order to avoid harming
persons and things.
• Before using the product for the first time, and periodically during its lifetime, check the integrity of the de-
vice structure and of the power cable to make sure there is no damage. In the event of damage, do not plug
in the cable and immediately take the product to an authorised FLAEM service centre or to your local dealer.
• The average life span of the accessories is approximately 6 months. The filter (A8) is for single patient use and
must be replaced within the period of use indicated on the packaging.
• Children and people who are not self-sufficient must use the device under the close supervision of an adult
who has read this manual.
• Some parts of the device are small enough to be swallowed by children; therefore, keep the device out of
the reach of children.
• Do not use the provided tubing and cables for any other purpose than those specified, as they can cause risk
of strangulation. Be particularly attentive with children and individuals with disabilities because they are often
unable to correctly assess risk.
• The apparatus is unsuitable for use in presence of flammable anaesthetic mixture with air, oxygen or nitrous
oxide.
• Always keep the power supply cable away from hot surfaces.
• Always keep the power cable away from animals (for example, rodents) which could damage the insulation.
• Do not handle the plug with wet hands. Do not use the device in damp conditions (for example when
taking a bath or shower). Do not immerse the device in water; in the event of immersion immediately
disconnect the plug. Do not remove or touch the immersed device; unplug the power cable first. Imme-
diately bring the device to an authorised FLAEM service centre or to your trusted dealer.
• Use the device only in dust-free conditions, otherwise treatment could be compromised.
• The device casing is not waterproof. Do not wash the device under running water or by immersion and keep
it safe from being sprayed by water or other liquids.
• Do not expose the device to particularly extreme temperatures.
• Do not place the device near sources of heat, in direct sunlight or in excessively hot rooms.
• Do not obstruct or put objects into the filter or its related housing in the device.
• Never obstruct the air inlets positioned on both sides of the device.
• Always use it on a rigid surface that is clear of obstacles.
• Make sure there is no material obstructing the air vents before each use.
• Do not insert any objects into the ventilation slits.
• Always unplug the power cable immediately after use.
• The device is equipped with an easy to inspect safety fuse in case of malfunction. Before doing so, unplug
the power cable. Repairs must be done only by authorised FLAEM personnel. Unauthorised repairs void the
warranty and may be hazardous for the user.
• The average duration of use intended for the device is 1000 h for the compressor and 600 h for the ultrasonic
nebuliser.
ATTENTION: Do not modify this device without authorisation from the manufacturer.
• The Manufacturer, the Vendor and the Importer shall be held responsible for safety, reliability and perfor-
mance only if: a) the device is used in compliance with the instructions for use; b) the wiring where the device
is being used is in compliance with safety regulations and current laws.
• The Manufacturer must be contacted to report problems and/or unexpected events related to operation.
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