operating conditions:
Storage conditions:
operating/storage atmospheric pressure: min. 69KPa; máx. 106KPa
APPLIED PARTS
Type B applied parts include: (C1,C2,C3,C4)
RF6 PLUS NEBULIZER
Medication minimum capacity: 2 ml
Medication maximum capacity: 8 ml
Operating
MMAD
pressure
1,2 bar
(1)
Data shown is in accordance with Flaem Nuova internal procedure I29-P07.5.
GmbH – Germany in compliance with the new European Standard for aerosol therapy units, Standard EN 13544-1. Further details are available upon request.
DEVICE DISPOSAL
In conformity with Directive 2002/96/EC, the symbol shown on the appliance to be disposed of
indicates that this is considered as waste and must therefore undergo "sorted waste collection".
The user must therefore take (or have taken) the above waste to a pre-sorted waste collection centre
set up by the local authorities, or else give it back to the dealer when purchasing a new appliance
of the same type. Pre-sorted waste collection and the subsequent treatment, recovery and disposal
operations favour the production of appliances made of recycled materials and limit the negative effects
of any incorrect waste management on the environment and public health. The unlawful disposal of the
product by the user could result in administrative fines as provided by the laws transposing Directive
2002/96/EC of the European member state in which the product is disposed of.
ELECTROMAGNETIC COMPATIBILITY
This device has been designed to satisfy requirements currently required for electromagnetic
compatibility (EN 60 601-1-2:2007). Electrical medical devices require special care. During
installation and use with respect to EMC requirements, it therefore required that they be installed
and/or used according to the manufacturer's specification. Potential risk of electromagnetic
interference with other devices, in particular with other devices for analysis and treatment. Radio
and mobile telecommunications devices or portable RF (mobile phones or wireless connections)
may interfere with the operation of electrical medical devices. For further information visit
www.flaemnuova.it. Flaem reserves the right to make technical and functional changes to the product
without notice.
Temperature: min 10°C; max 40°C
RH Air humidity: min 10%; max 95%
Temperature: min -25°C; max 70°C
RH Air humidity: min 10%; max 95%
BREATHABLE FRACTION
(μm)
(2)
< 5 μm (FPF) %
2,8
76
(2)
In vitro characterization carried out at the Inamed Research GmbH Co. KG on behalf of TÜV Rheinland LGA Products
DELIVERY ml/min
(2)
open valve-holder
MAX
0,54
10
(1)
closed valve-holder
MIN
0,21