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Operating instructions VENTA Multi Care 16_ 5752 2434
GA 5752 2434 EN 13
13
Introduction
1
VENTA MC 16 septic fluid suction pump
1.4.7
Use in accordance with the intended purpose
Product
As per Annex IX of the 93/42/EEC Medical
Products Directive, this unit is a Class IIa item.
As prescribed by that directive, only persons
skilled in the use of the product and medical
personnel may use this product, provided that
they have been instructed by an authorised in-
dividual on the use of the product.
This product is to be used exclusively for hu-
man medicine.
When employed in a commercial or business
use this product shall be entered in the invento-
ry.
Accessories
Accessories or combinations of accessories
may be utilised only when and as indicated in
these Operating Instructions.
Other accessories, combinations of accesso-
ries and consumable items may be used only if
they have a valid certification, are intended ex-
pressly for the particular use and will not ad-
versely affect performance, the prescribed
ambient conditions or safety requirements.
1.4.8
Applicable standards
The product satisfies the basic requirements
set forth in Annex I to the 93/42/EEC Directive
drafted by the Medical Products Council (Medi-
cal Products Directive) as well as the applicable
national (German) codes and the Medical Prod-
ucts Act in Germany.
The applicable standards include the fol-
lowing:
• EN 837-1: 1997-02
Pressure measurement devices
Part 1: Bourdon tube pressure gauges – di-
mensions, metrology, requirements and test-
ing
• EN ISO 10079-1: 2000-03
Medical suction equipment
Part 1: Electrically powered suction equip-
ment
• EN 60601-1: 1996-03
Medical electrical equipment
Part 1: General requirements for safety
• EN 60601-1-2: 2002-10
Medical electrical equipment
2. Collateral standard: Electromagnetic com-
patibility – Requirements and tests
• EN 12218: 2002- 07
Rail systems for supporting medical equip-
ment
• EN ISO 14971: 2001-03
Medical devices – Application of risk man-
agement to medical devices