MEDAP WISTA SP 1070, Руководство по эксплуатации

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Introduction
Basic requirements
GA 5752 1555 DE 28
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1.4 Basic requirements
1.4.1 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 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.
1.4.2 Applicable standards
The product satisfies the basic requirement 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
Directive 93/42/EEC.
1.4.3 Intended purpose
Name: TWISTA SP 1070
Main function: Aspiration of secretion, blood, serous fluids 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, 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.