FLAEM Rhino Clear Manual De Instrucciones página 12

The accessories that can be sterilised are 1A-1B-1C-2-3-4-5.
Equipment: Fractionated vacuum overpressure steam steriliser in accordance with EN 13060.
Directions: 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 121°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.
NASAL WASH SYSTEM TECHNICAL FEATURES
Mod.: Rhino Clear®
Operating Conditions:
Temperature: min 10°C; max 40°C
Relative humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max 106KPa
Capacity: medication maximum 10 ml
Type BF applied parts are: patient accessories (1A-1B-1C)
Compliant with Directive 93/42 EEC-
Family of FLAEM compressors
F400
F700/F1000
F2000
(1)
Tests performed with 0.9% NaCl saline solution, according to the Flaem internal procedure
SYMBOLS
EC Marking medi-
cal ref. Dir 93/42
EEC and subse-
quent updates
LOT
Lot number
Storage conditions:
Temperature: min -25°C; max 70°C
Relative humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max 106 KPa
Check the instruc-
tions for use
Manufacturer
10
10 ml Delivery Time
2 minutes (approx)
2 minutes (approx)
2 minutes (approx)
In compliance with: Euro-
pean Standard EN 10993-1
''Biological Evaluation of
medical devices'' and Euro-
pean Directive 93/42/EEC
"Medical Devices. " Phthalate-
free. In compliance with: Reg.
(EC) no. 1907/2006
(1)