Introduction
Basic requirements
10
GA 5752 3125 GB 10
1
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 Products 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:
FINA FRV VAC
Main function:
Aspiration of secretion, blood, serous fluids, vomit and rinsing fluids
along with any contained particles
Medical indications /
application:
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 (aspiration of wound cavities, abscesses) and
bronchial aspiration of adults.
Specification of the main
function:
Drainage and temporary collection of body fluids. For the supply of
vacuum, FINA FRV VAC is connected to a terminal unit for vacuum
of a central medical gas supply system with a pressure of -100 kPa
to -60 kPa. A septic fluid jar, which has to be used, allows for
temporary collection of the drained body fluids.
User profile:
Doctor, medically trained staff
Patient groups:
Surgical aspiration: patients of all ages; bronchial aspiration of
adults
Application organ:
Natural and artificial body orifices
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 vacuum source. The application of
the product may only be performed by medically trained and
instructed staff.
Contraindications:
The FINA FRV VAC may not be used for the following purposes:
• Outside the medical sector
• In MR areas
• In the home care sector
• Being operated directly by the patient
• If not reducing the vacuum of the central gas supply poses a
danger for the patient (e.g. in drainage, in paediatrics and neo-
natology). Usage in combination with disposable thoracic drain-
age systems with integrated vacuum regulation is excepted.
• For vacuum extraction
• For the aspiration of flammable or explosive liquids
• For the aspiration of smoke that is generated during HF and
laser surgery without the connection of an intermediate smoke
filter
• With central gas supply systems with supply pressures other
than -100 kPa to -60 kPa
