Introduction
Basic requirements
12
GA 5752 2300 GB 26
1
1.4.3
Trolley
1
2
3
Fig. 3:
Overview of trolley (REF 5752 5320)
1 Handle screw
3 Double castors with locking brake
2 Equipment rail
1.5
Basic requirements
1.5.1
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.
Gemäß dieser Richtlinie darf nur medizinisches Fachpersonal dieses Produkt benutzen, welches
von einer autorisierten Person in den Gebrauch des Produkts eingewiesen wurde.
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.
1.5.2
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 Devices Act in Germany. This has also been demonstrated
