Introduction
Applicable standards
GA 5752 2806 GB 10
11
1
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 the 93/42/EU Directive drafted
by the Medical Products Council (Medical Products Directive) as well as the applicable national
(German) codes and the Medical Products Act in Germany. This has also been demonstrated
through the application of the corresponding standards, which have been harmonised with the
93/42/EEC Directive.
1.5.3
Intended purpose
Name:
FINA FRV O2 and AIR
Main function:
The FINA FRV O2 and AIR may be used for the following main
functions:
• In conjunction with a gas-jet pump for aspiration of secretion,
blood, serous fluids, vomit and rinsing fluids along with any con-
tained particles
• In conjunction with a hand-held nebuliser to provide metered
administration of medication aerosols
Medical indications /
application:
Aspiration: For all aspirations, where a regulation of the vacuum
strength is not necessary and a regulation of the volume flow is
sufficient, e.g. general surgeries (e.g. aspiration of wound cavities,
abscesses) and bronchial aspiration of adults
Drug administration: Together with a hand-held nebuliser
administration of water soluble drugs via an inhalation mask
Specification of the main
function:
Connection of FINA FRV O2 or AIR is made to a central oxygen or
compressed air supply with a supply pressure of 300 to 500 kPa
±-10 % or to the pressure regulator of an oxygen gas cylinder,
whereby the initial pressure of the pressure regulator lies between
300 and 500 kPa ±-10 %.
Aspiration: Drainage and temporarily collection of body fluids. A
septic fluid jar which has to be used, allows a temporary collection
of the derived body fluids.
Drug administration: 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 mouth and nose.
User profile:
Doctor, medically trained staff
Patient groups:
Aspiration: Surgical aspiration: Patients of all ages; bronchial
aspiration of adults
Drug administration: Patients of all ages
Application organ:
Aspiration: Natural and artificial body orifices
Drug administration: Lung
