FLAEM Delphinus Manual De Instrucciones página 6

hypochlorite), specific for disinfection and is available in all pharmacies.
Procedure:
- Fill a container, suitable to contain all the individual components to be disinfected, with a solution of
drinking water and disinfectant, while respecting the proportions indicated on the packaging of the
disinfectant itself.
- Completely immerse each individual component in the solution, taking care to avoid the formation
of air bubbles in contact with the components. Leave the components immersed for the period of
time indicated on the packaging of the disinfectant, and associated with the concentration chosen to
prepare the solution.
- Remove the components now disinfected and rinse thoroughly with lukewarm drinking water.
- After sanitization shake the accessories vigorously and place them on a paper towel, or alternatively,
dry them with a jet of hot air (e.g. using a hair dryer).
- Dispose of the solution as recommended by the disinfectant manufacturer.
STERILIZATION
The accessories that can be sterilized are (C3-C4-C6.1-C6.2-C6.3-C6.4).
The sterilization procedure described in this paragraph is effective only if all the prescriptions herein
are met, all the components involved are previously sanitized and the procedure itself is validated
according to ISO 17665-1 rule.
Unit: Steam sterilizer with fractionated vacuum and overpressure according to EN 13060 rule.
Procedure: Package each component to be treated in sterile barrier system or packaging complying
with EN 11607 rule. Place the packed components in the steam sterilizer. Run the sterilization cycle
according to the instructions manual of the device, selecting a temperature of 134° C and a duration
of 10 minutes Storage: Store sterilized components as per instructions of the sterile barrier package or
system chosen.
AIR FILTER
The device has a suction filter (A3) that should be replaced when it is dirty
or changes color. Do not wash or reuse the same filter. Regular replacement
of the filter is required to help and ensure correct performance of the
compressor. Check the filter on a regular basis. Contact your local dealer or
authorized service center for spare filters.
To replace the filter: Insert a flathead screwdriver between the edge of the filter and the body. Lift the
filter and remove it by turning and pulling it upwards. The filter has been designed so that it is always
fixed in its seat. Use original FLAEM accessories only.
AvAILABLE SPARE PARTS
Description
- RF6 PLUS nebuliser kit composed of:
nebuliser, mouthpiece with valve and nasal prong
- 1 m connection tube
- Mask Set composed of: adult mask, pediatric mask and elastic band ACO462P
- Spare air filter kit (2 pcs) ACO164P
SYMBOLS
Class II device
Important: check the operating instructions
Switch off
Switch on
Complies with: European standard EN
10993-1 "Biological Evaluation of Medical
Devices" and European Directive 93/42/
EEC "Medical Devices"
Enclosure protection rating: IP21.
IP21
(Protected against solid bodies over 12 mm. Protected
against access with a finger; Protected against vertically
falling water drops.)
Manufacturer
Tipe BF applied part
Alternate current
Hazard: electrocution.
Consequence: Death.
Do not use device while taking
a bath or shower
CE Medical Marking ref. Dir.
93/42 EEC and subsequent
0051
amendments
TÜV Certification
ref. EN 60601-1 3° Ed.
EN 60601-1-11
Serial number of device
4
Code
ACO368P
ACO35