MEDAP 5752 4916, Руководство по эксплуатации

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Introduction
Basic requirements
GA 5752 4981 GB 15
9
1
When employed in a 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
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 is certified by compliance
with harmonised standards such as IEC 60601-1 and related standards and the respective
special sections.
1.5.3 Intended purpose
Name: LS FLOW
LS 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 LS 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 a nose latch for patients
breathing by themselves
Together with a hand-held nebuliser administration of water soluble
drugs via an inhalation mask
Specification of the main
function:
Supply of oxygen or compressed air. For oxygen / compressed air
supply, the LS FLOW is connected to an oxygen / compressed air
terminal unit of a central medical gas supply system having a
supply pressure within the supply pressure specified on the
product. 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
connected to the hand-held nebuliser onto the mouth and nose.
User profile: Doctor, medically trained staff
Patient groups: Patients of all ages
Application organ: Lung
Application time: For continuous operation; in practice, short-term use on the patient
(< 30 days)
Application site: The application site is the clinical environment and doctor’s
practices which have a central oxygen / compressed air system.
The application of the product may only be performed by medically
trained and instructed staff.