Technical Specifications - FLAEM Rhino Clear Mobile P0907EM Manual De Instrucciones

6. Technical specifications

Model:
Recharger base voltage:
Nebulisation chamber max. capacity:
Nebulisation time for 10 ml
Cumulative mass percentage oversize > 10 micron: between 95 and 96 %
(Fraction not inhaled useful for the treatment of the upper airways).
using the procedure devised by the Pharmaceutical Department of Parma University.
Average values measured with 0.9% NaCI saline solution in compliance with Flaem internal procedure.
(2)
Nasal irrigator dimensions:
Nasal irrigator weight:
In conformity with EEC directive 93/42:
Approvals:
Recharger base dimensions:
Total weight (recharger base with
unit and accessories):
Nasal irrigator internal batteries:
Operating conditions:
Storage conditions:
Operating/storage atmospheric pressure:
The type BF applied parts a re the 3 nasal adaptors (1a, 1b, 1c)
7. Symbols
Certification TÜV
CE Medical Marking ref. Dir.
93/42 EEC and subsequent
amendments
Important: check the opera-
ting instructions
IP45 Protected against solid
foreign bodies with Ø 1 mm
IP45
or larger and against jets of
water
Minimum and maximum
room temperature
):
(2
Complies with: European standard EN 10993-1 "Biological Evaluation of
Medical Devices" and European Directive 93/42/EEC "Medical Devices".
Phthalates free. In conformity with Reg. (EC) no. 1907/2006
Serial number of device
Type BF applied part
Minimum and maximum air
moisture
P0907EM
220-230V~ 50-60Hz / 18VA
15 ml
approx. 2 minutes (1 ml in approx. 12 seconds)
(1) Values measured with a computerised laser diffractometer Malvern Mastersizer,
7x6x15.5h cm
210 g
15x9x8h cm
480 g
Ni-MH, rechargeable, 1.2V 620/650mAh
Temperature: min +5°C; max 40°C
Air humidity: min 15%; max 90% RH
Temperature: min -10°C; max 45°C
Air humidity: min 10%; max 75% RH
min. 690 hPa; max. 1060 hPa P
Operating instructions
16
(1)
Class II device
Manufacturer
Alternating current
Minimum and maximum
atmospheric pressure