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Les langues disponibles
Les langues disponibles
6. SYMBOLS
CE Medical Marking ref. Dir. 93/42
EEC and subsequent amendments
Important: check the operating
instructions
Batteries
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
Minimum and maximum room
temperature
Minimum and maximum
atmospheric pressure
7. TECHNICAL CHARACTERISTICS
Model:
Input voltage :
Max capacity of the nebulisation slot :
Delivery
(saline solution NaCl 0.9%):
Cumulative Percentage of Mass Oversize > 10
(Non-respirable fraction useful for the treatment of the upper respiratory tract) -
diffractometer Malvern Mastersizer according to the procedure of the Pharmaceutical Department of the University of Parma.
Nasal douche dimensions:
Nasal douche weight (no batteries):
Complying with directive 93/42 ECC
Approvals:
Nasal douche batteries :
Conditions of use:
Storing conditions:
Atmospheric pressure in operating/storage conditions: min. 690 hPa; max. 1060 hPa P
Applied BF-type parts are:
TÜV approval
Manufacturer
BF type applied part
Protected against solid foreign
bodies with Ø 1 mm or larger and
against jets of water
Minimum and maximum air moisture
Serial number of device
P0709EM
3,0 Vdc – 4,5 W
15 ml
5 ml/min (10 ml delivered in 2 min)
micron between 95 e 96 %
Values measured with a computerized laser
(1)
7x6x15,5h cm
185 g
2 1,5 V alcaline batteries (AA type)
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
(1A-1B-1C)
7
(1)
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