Device Description; Intended Use / Indication; Application Area And Conditions Of Use - Krömker UltraNeb Instrucciones De Uso

5.

Device description

5.1 Device description
The device consists of a washable plastic housing
with internal electronic components and an
attachable nebuliser chamber. The device is started
up and controlled with push-buttons.
The base of the nebuliser chamber contains an
oscillating quartz, which causes the liquid in the
container to nebulise through its high-frequency
oscillations. A blower located in the housing conveys
the aerosol through the patient tube to the desired
breathing area of the patient. The aspirated air is
passed through a bacteria filter before nebulisation.
The device is designed for a service life of 10 years.
Three different set-up variants are provided for
different installation options of the ultrasonic
nebuliser:
− Table-top version:
The device stands on a table or on a horizontal
and fixed support surface
− Wall-mounted version:
The device is fastened to a device rail 25x10mm
(DIN)
− Carriage version:
The device is fastened to the stand tube of a
carriage
5.2

Intended use / indication

The ultrasonic nebulisers are exclusively intended
for humidifying the respiratory air of spontaneously
breathing patients from the age of 16 years and for
aerosol therapy.
Aerosol therapy should only be carried out according
to the instructions of a doctor.
Inhalation for humidification of the respiratory tract
using distilled water or brine solution 0.9%.
With this application the aerosol causes a mucus
solution in the respiratory tract and thus promotes
the expectoration of the secretion. In addition, the
dilution of the bronchial secretion supports the
body's own cleaning function of the lungs.
All other uses are deemed non-intended use. The
manufacturer shall not be liable for damage caused
by non-intended use.
36
5.3

Application area and conditions of use

The medical device shall be used exclusively in rooms
designated for clinical practice.
D WARNING!
Danger of explosion!
− The medical device is not approved for operation
in areas in which oxygen concentrations of more
than 25% by volume, flammable or explosive gas
mixtures may occur.
− Do not use the device together with flammable or
explosive liquids.
D WARNING!
Patient endangerment!
− Do not use the ultrasonic nebuliser on patients
requiring ventilation.
− Do not install ultrasonic nebulisers in breathing
systems.
− Do not use the ultrasonic nebuliser with a
respiratory mask, tracheal cannula.
This can lead to fluid accumulations in the
respiratory organs.
D WARNING!
Risk of infection!
Do not use ultrasonic nebulisers without a bacteria
filter.
The field of application of the ultrasonic nebuliser
USV 2010 is a clinical environment, medical practice,
senior citizens' or nursing home and in the military
medical service by qualified personnel trained in
the specific application. The ultrasonic nebuliser is
intended for short-term use.
Due to the alveolar particle size of the mist, special
care must be taken with regard to hygiene when
preparing and performing inhalation.
The air flow is only sufficiently filtered if a suitable
bacteria filter is used.
Replace the bacteria filter after 24 hours of use or
according to the special instructions of the respective
filter manufacturer.
Clean reusable tubing daily or when changing
patients.
Replace disposable tubes and mouthpieces daily or
when changing patients.
Device description
96200-114 – 10 – 15.07.2020