EC Declaration of Conformity
For the pump (0806278) :
Press the
“orange” switch to select Static Pressure. This switch activates or
deactivates the alternating air flow from the pump to the mattress and gives
continuous flow.
OPERATION USE
We declare the conformity of the above product to the provisions of the Medical
Equipment Directive 93/42/EEC and the Greek National Legislation
ΔΥ8δ/Γ.Π.οικ.130648. ΦΕΚ 2198Β/02-10-2009
Each product in this statement meets the technical specifications contained in its
technical documentation If the appropriate maintenance will be provided and the
product will be used according the “instruction of use” then the product is safe and
effective and does not endanger the health safety of patient’s, user and or third
parties,
This declaration is issued on the basis of a certificate of registration in the
Manufacturer Register of Medical Devices of the Competent Authority (EOF).
The product belongs in Class I, Classification rule 1 & Corresponds to the Medical
Device Directive: 93/42/EEC
