Flaem P0709EM - Important Warning

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4. Important warning
Just as any electrical device, especially in the presence of children, Rhino Clear Sprint needs to be used
carefully.
• The nasal douche is not to be used as a toy. The upmost care and attention is required when the
douche is used by children or when children are present.
• In the presence of children or of people who are not self-sucient, use the nasal douche under the
careful supervision of an adult who has read the enclosed manual.
• Do not use batteries with a dierent alimentation other than those listed on the plate.
• Remove the batteries before storing Rhino Clear Sprint.
• It is a device which cannot be used in the presence of ammable anaesthetics with oxygen or with
nitrogen protoxide.
• The casing of the device is not protected against the penetration of liquids. Do not wash the device
under running water or by immersing it and keep it away from splashes of water or of other liquids.
• Do not use the nasal douche when showering or bathing.
• Do not expose the device or the batteries to extreme temperatures. Do not place the device and the
battery near sources of heat, sunlight or in extremely hot places.
• Repairs may only be performed by authorised personnel following the information in the restricted
area of the website www.aem.it. Unauthorised repairs void the warranty and may pose a danger for
the user.
• ATTENTION: Do not modify this device without authorisation from the manufacturer.
• The Manufacturer, Importer and Seller shall be liable for the safety, reliability and performance only
if the device is used in accordance with the operating instructions.
• The manufacturer must be contacted about any problems and/or unexpected events concerning
operation and for any clarications on use, maintenance or cleaning.
• Microbial contamination: you must foresee a personal use of the nasal shower and accessories to
avoid any risk of infection.
• Interactions: the materials used have been tested according to the bio-compatibility standards (ISO
10993) in compliance with the essential requirements of the Medical Device Directive 93/42 EEC.
• Clean the device after each use, to assure optimal hygiene and to improve the service life and
operation of the device.
• Do not obstruct the suction valve on the bottom of the douche compressor body; never insert
anything into the cover.
• This Medical Device is intended for direct use by the patient.
• The time it takes to switch from operating condition is about 4 hours.
SYMBOLS
Model: P0709EM
Input voltage 3,0 Vdc – 4,5 W
Max capacity of the nebulisation slot 15 ml
Nebulisation time for 10 ml of physiological solution NaCl 0,9% about 2 minutes (1 ml about 12
seconds)
Cumulative Percentage of Mass Oversize > 10 microns between 95 and 96 %
(1)
(Non-respirable fraction useful for the treatment of the upper respiratory tract) -
(1)
Values measured with a computerized laser diractometer
Malvern Mastersizer according to the procedure of the Pharmaceutical Department of the University of Padova.
Nasal douche dimensions 7x6x15,5h cm
Nasal douche weight (no batteries) 185 g
Complying with directive 93/42 ECC
Approvals:
Nasal douche batteries 2 1,5 V alcaline batteries (AA type)
Conditions of use: Temperature: min +5°C; max 40°C
Air humidity: min 15%; max 90% RH
Storing conditions: Temperature: min -10°C; max +45°C
Air humidity: min 10%; max 75% RH
Atmospheric pressure in operating/storage conditions: min. 690 hPa; max. 1060 hPa P
Applied BF-type parts are: (1A-1B-1C)
Electromagnetic compatibility
This device was designed to meet the current requirements for electromagnetic compatibility (EN 60 601-1-2:2015). For additional
information please go to www.aem.it. The Medical device may be subject to electromagnetic interference if other devices are used
for specic diagnosis or treatments.
Flaem Nuova reserves the right to make technical and functional modications to the product with no prior notice.
Disposal: For an adequate disposal, remember that the device contains batteries. In compliance with Directive 2012/19/EC, the
symbol on the device indicates that the device to dispose of is considered as waste, and should therefore be disposed of
accordingly. The user shall take the abovementioned waste (or have it taken) to a proper separate collection of waste centre
created by local administrations, or hand it in to the seller when buying a new device of the same kind. The separate collection
of waste and the following operations of treating, recycling and disposal, favour the production of devices with recycled
materials and limit the negative eects on the environment and on health, caused by unappropriate waste handling. The unlawful
disposal of the product by the user could result in administrative nes as provided by the laws transposing Directive 2012/19/EC of
the European member state or of the country in which the product is disposed of.
parts vigorously in order to eliminate any remaining droplets of water. Then, place the parts on a paper
towel or dry them using a jet of warm air. WARNING: Should your nasal irrigator not atomize properly
after cleaning and sanitizing is performed, do not use sharp tools (i.e. screwdrivers, scissors ends, nee-
dles, hairpins, etc.) to try to clean or unclog the atomizer or atomization chamber holes as this could
damage these parts and impair the correct operation of the unit. Instead, perform additional cleaning
and sanitizing cycles as described in the instruction manual and above recommended, until the nasal
irrigator starts to operate properly again.
Batteries
Medical CE marking in compliance
with Directive 93/42 and subsequent
amendments. In accordance with EN
60601-1-11
BF type applied part
Follow usage instructions
Protected against solid foreign bodies
with Ø 1 mm or larger and against jets
of water
TÜV approval