Introduction
Basic requirements
GA 5752 2300 GB 26
13
1
through the application of the corresponding standards which have been harmonised with
Directive 93/42/EEC.
1.5.3
Intended purpose
Name:
BORA UP 2080
BORA UP 2080 OP
Main function:
Aspiration of secretion, blood, serous fluids, vomiting and rinsing
fluids along with any contained particles and temporary collection of
these fluids
Medical indications /
application:
For all applications which require aspiration, such as general
surgeries (e.g. aspiration of wound cavities, abscesses), aspiration
of the nasopharyngeal cavity, bronchial aspiration, during
endoscopy for aspiration of secretions or rinsing fluids and in
neurosurgery
Specification of the main
function:
Drainage and temporarily collection of body fluids. By means of an
electrical aspiration pump, a negative pressure will be created. A
septic fluid jar which has to be used, allows a temporary collection
of the derived body fluids.
User profile:
Doctor, medically trained staff
Patient groups:
Patients of all ages with and without restrictions
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. The application of the product may only be performed by
medically trained and instructed staff.
Contraindications:
The BORA UP 2080 may not be used for the following purposes:
• Outside the medical sector
• In the home care sector
• Being operated directly by the patient
• For vacuum extraction
• For smoke evacuation
• Without smoke evacuation filter, when aggressive vapours are
also generated during the suction of liquids due to easily volatile
components (e.g. when using iodine as disinfectant)
• For the aspiration of flammable or explosive liquids
• In areas prone to explosion risks (AP-M, APG areas)
• For drainages in the low vacuum range (e.g. thoracic and wound
drainage)
• In the standard equipment version in heart surgery and in
operations on the central nervous system. This requires
separate equipment providing reliable protection against
equipotential bonding between the patient and contacting, fluid-
filled metal parts.
The product is:
Active
