M-neb Dose+, Instructions For Use Manual

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22.0 EC Certificate of Conformity
Product
M-neb
®
dose
+
mesh nebulizer MN-300/8
REF
MN-300/8
Classification The device M-neb
®
dose
+
mesh nebulizer REF MN-300/8, is classified
as a product of the class lla pursuant to the COUNCIL DIRECTIVE
93/42/EEC of 14 June 1993 concerning medical devices, as last
amended by Directive 2007/47/EC of the European Parliament and of
the Council of 5 September 2007 in accordance with the classification
criteria of Rule 11 listed in Annex IX.
UMDNS number 12-719 (nebulizer, ultrasonic)
Manufacturer Nebu-Tec med. Produkte Eike Kern GmbH
Kreuzfeldring 17 - 63820 Elsenfeld
– Germany
We hereby declare, as the exclusive responsible manufacturer, that the aforementioned device
conforms to the relevant EC Directive 93/42/EEC Annex II, Section 3 (complete QM system).
Notified body TÜV Rheinland LGA Products GmbH
Tillystraße 2
90431 Nürnberg
Germany
ID 0197
Conformity assessment
procedure EC Directive 93/42/EEC Annex II, Section 3
EC certificate HD 60101825 0001
CE mark since 2016
23.0 Warranty
We grant you a warranty of 24 months from the date of purchase on your M-neb
®
dose
+
mesh nebulizer MN-300/8.
We can grant you this warranty on the M-neb
®
dose
+
mesh nebulizer MN-300/8 (control
unit) (Item no. 20100262) and the M-neb
®
power cord MN-300/X (type: GTM41076-0605-
A) (Item no. 20100206).
We grant you a warranty of 6 months on the integrated rechargeable batteries of the M-
neb
®
dose
+
mesh nebulizer MN-300/8 (control unit).
The M-neb
®
dose
+
nebulizer unit MN-300/8 (with M-neb
®
dose
+
mouthpiece MN-300/8)
(Item no. 20100268) and the M-neb
®
dose
+
mouthpiece MN-300/8 (Item no. 20100269)
are wear parts and thus excluded from the warranty.
Damage caused by improper handling of the device is not covered by the warranty. The
warranty terminates upon unauthorized interference to the device.
24.0 Release notes
Version: NT_MN-300-8_IFU-E_A