Technical Specifications - FLAEM RF7 Plus Manual De Instrucciones

a hot cycle.
DISINFECTION
Accessories 1-2-3-4-5-6-8-9-11.1-11.2-11.3-11.4. can be disinfected.
The disinfectant must be an electrolytic chloroxidizer (active principle: sodium hypochlorite)
specific for disinfecting, which is available in any pharmacy.
Implementation:
- Fill a container big enough to hold all of the parts to disinfect with a solution of potable
water and disinfectant, according to the proportions indicated on the packaging of the
disinfectant.
- Completely immerse each part in the solution, taking care to avoid the formation of air
bubbles on the parts. Leave the parts immersed for the amount of time indicated on the
packaging of the disinfectant associated with the concentration chosen for the solution.
- Remove the disinfected parts and rinse abundantly with warm potable water.
- Dispose of the solution following the instructions provided by the disinfectant
manufacturer.
If you want to also perform the STERILISATION, jump to the STERILISATION paragraph.
After having disinfected the accessories, shake them vigorously and place them on a paper
towel. Alternatively, dry them with a jet of hot air (for example, from a hair dryer).
STERILISATION
Accessories 1-2-5-6-9-11.1-11.2-11.3-11.4 can be sterilised.
Device: Fractionated vacuum overpressure steam steriliser in accordance with EN 13060.
Implementation: Wrap every single part to be treated with a sterile barrier system or
packaging in accordance with Norm EN 11607. Place the packed components in the steam
steriliser. Run the sterilisation cycle according to the operating instructions of the device by
selecting a temperature of 134°C and a time of 10 minutes first.
Storage: Store the sterilised parts as per the instructions for use of either the sterile barrier
system or packaging.
The sterilisation procedure is validated in its conformity to ISO 17665-1.
For the CLEANING, SANITISATION, DISINFECTION, STERILISATION of accessories 7
follow the instructions in the instruction manual.

TECHNICAL SPECIFICATIONS

RF7 Dual Speed Plus Nebulizer
Operating conditions:
Temperature: min 10°C; max 40°C
Air humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max 106KPa
In compliance with 93/42/EEC Directive
Minimum fill volume: 2 ml
Maximum fill volume: 8 ml
FLAEM com-
Pressure
pressor range
Portable 0.75 bar
F700/F1000 1.00 bar
F2000 1.40 bar
Data shown is in accordance with Flaem Nuova internal procedure I29-P07.5.
(1)
In vitro testing certified by TÜV Rheinland LGA Products GmbH – Germany in compliance with the European
(1)
Standard EN 13544-1 ANNEX CC for nebulizing systems. More details are available on request.
Storage conditions:
Temperature: min -25°C; max 70°C
Air humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max 106KPa
APPLIED PARTS
The applied parts of type BF are:
patient accessories (1,2,3,4,5,6,7)
MMAD (μm)
(2)
Min
With Max
valve
2.95 2.44
2.72 2.53
2.21 2.38
10
BREATHABLE
(2)
FRACTION
(1)
< 5 μm (FPF) %
Min
With Max
valve
74.7 80.7
77.8 79.6
84.2 81.5
DELIVERY ml/min
Min
With Max
valve
0.18 0.42
0.23 0.53
0.29 0.65