Atmos MEDAP FINA DFLOW, Руководство по эксплуатации

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Introduction
Basic requirements
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GA 5752 2804 GB 18
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1.5 Basic requirements
1.5.1 Use in accordance with the intended purpose
Product
As per Annex IX to the Medical Devices Directive 93/42/EEC, this product belongs to class IIa.
In accordance with this directive, the product may only be used by persons who have been
instructed how to use this product by an authorised person.
This product is to be used exclusively for human medicine.
When employed in commercial or business use, this product must be entered in the inventory.
Accessories
Accessories or combinations of accessories may be utilised only as and when indicated in these
operating instructions.
Other accessories, combinations of accessories and consumable items may be used only if they
have a valid certification, are intended expressly for the particular use and will not adversely
affect performance, the prescribed ambient conditions or safety requirements.
1.5.2 Applicable standards / directives
The product satisfies the basic requirements set forth in Annex I to Council Directive 93/42/EEC
concerning medical devices (Medical Devices Directive) as well as the applicable national
(German) codes and the Medical Devices Act (MPG) in Germany. This has also been
demonstrated through the application of the corresponding standards which have been
harmonised with Directive 93/42/EEC.
1.5.3 Intended purpose
Name: FINA FLOW
FINA DFLOW
Main function: Designed for measuring the flow and determining the precise
dosage for the supply of oxygen and compressed air. In conjunction
with a hand-held nebuliser, the FINA FLOW is used to provide
metered administration of medication aerosols.
Medical indications /
application:
Inhalation and insufflation of oxygen within the scope of oxygen
enrichment via an inhalation mask or nose latch for patients who
can breathe independently.
Together with a hand-held nebuliser, administration of water-soluble
medications via an inhalation mask.
Specification of the main
function:
Supply of oxygen or compressed air. For oxygen / compressed air
supply, FINA FLOW is connected to a terminal unit for oxygen /
compressed air of a central medical gas supply system with a
pressure of 500 kPa ± 10%. For humidification of oxygen from the
central gas supply system, a humidifier may additionally be
connected. Supply of oxygen to the patient takes place via
connection tubes and an inhalation mask or a nose latch. The
administration of medication aerosols via compressed air takes
place via connection tubes to a hand-held nebuliser. The patient
presses the inhalation mask of the hand-held nebuliser onto the
mouth and nose.
User profile: Doctor, medically trained staff