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DTF MEDICAL PURENEB AEROSONIC: PURENEB AEROSONIC+ Instructions For Use Manual

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associated with PURENEB EXTRANEB and EXTRANEB SONIC nebulizing kits:
According to the European Standard "Nebulizing systems" EN 13544-1
« CLASSIC » OR STANDARD MODELS:
FOR LUNG OR BRONCHIAL TREATMENTS
AEROBOX
AEROBOX
« SONIC » MODELS:
FOR ENT & SINUSITIS TREATMENTS
AEROSONIC
AEROSONIC
INSTRUCTIONS FOR USE
®
PURENEB
NEBULIZING SYSTEMS
NL9 range –NL11S range
(adult and paediatric models)
Directive 93/42/EEC – Medical Devices Class IIa
(ref. ABOX)
+
(ref. ABOX+)
(ref. AOHBOX)
+
(ref. AOHBOX+)
LA DIFFUSION TECHNIQUE FRANCAISE
19 rue de la Presse
Tel. 33.(0)4.77.74.51.11 - Fax 33.(0)4.77.79.67.72 - e-mail : dtf@dtf.fr - www.dtf.fr
0459
(1998)
0459 (2001)
0459 (2006)
0459 (2011)
CS 60132
42003 SAINT-ETIENNE Cedex 1 France
Video « How to use your
Atomisor nebulizing system » is
available on www.dtf.fr
Non contractual pictures
A.NU.EN.008.0219

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Summary of Contents for DTF MEDICAL PURENEB AEROSONIC: PURENEB AEROSONIC+

  • Page 1 Video « How to use your Atomisor nebulizing system » is available on www.dtf.fr Non contractual pictures LA DIFFUSION TECHNIQUE FRANCAISE 19 rue de la Presse CS 60132 42003 SAINT-ETIENNE Cedex 1 France Tel. 33.(0)4.77.74.51.11 - Fax 33.(0)4.77.79.67.72 - e-mail : dtf@dtf.fr - www.dtf.fr A.NU.EN.008.0219...

  • Page 2: Table Of Contents

    CONTENTS CLASSIFICATION and ELECTROMAGNETIC COMPATIBILITY PRESENTATION 2.1. Classic aerosols = without sound vibrations 2.2. Sonic aerosols = with 100 Hz sound vibrations Identification 2.4. Symbols used on devices PRECAUTIONARY MEASURES DESCRIPTION AND PERFORMANCES 4.1. AEROBOX and AEROBOX+ models 4.2. AEROSONIC and AEROSONIC+ models 4.3.

  • Page 3: Classification And Electromagnetic Compatibility

    CLASSIFICATION and ELECTROMAGNETIC COMPATIBILITY Device class Device class in electrical safety Type of applied parts Protection level IP 30 3: protected against ingress of solid foreign objects larger than 2.5 mm; 0: not protected against vertical water drops falls. Expected shelf life of accessories 1 year Expected shelf life of the device 5 years...
  • Page 4 WARNING: Portable RF communication devices (including peripherals such as antenna cables and external antennas) should not be used closer than 12 inches (30 cm) to any part of the PURENEB device, including cables specified by the manufacturer. Otherwise, performance may be impaired. WARNING: If the device malfunctions due to electromagnetic disturbances, the performance of the device may be impaired and result in delayed patient care.

  • Page 5: Presentation

    2. PRESENTATION What is an aerosol? SONIC An aerosol is an air suspension of very fine medicinal particles. Their size is below 10 microns. CLASSIC Depending on the treatment, the device will be used as a classic aerosol or as a sonic aerosol. 2.1.

  • Page 6: Symbols Used On Devices

    2.4. Symbols used on devices Device type BF Device class 2 (electric) See instructions for use Manufacturer Dangerous voltage Caution / Warning Serial number Alternative current Device reference Keep dry Fragile Keep away from light Classic Modus Sonic Modus PRECAUTIONARY MEASURES ...
  • Page 7  The patient should be relaxed, seated in an upright position. Video « How to use your Atomisor nebulizing system » is available and can be downloaded on www.dtf.fr  Breathe deeply: * through the mouth with a classic aerosol, using rather the mouth piece, for broncho-pulmonary treatments.

  • Page 8: Description And Performances

    DESCRIPTION and PERFORMANCES Caution: Check the kneecap is well assembled on the mask. CLASSIC AEROSOL COMPRESSORS (Broncho-pulmonary treatments) AEROBOX AEROBOX+ 4.1. EXTRANEB+ NL9MXBR nebulizing kit with mouth piece and mask Carrying bag on request: ref. MBOXA SONIC AEROSOL COMPRESSORS (ENT treatments) For a broncho-pulmonary treatment, the Sonic Aerosol compressor is used in classic mode (without vibrations) and can be equipped with the EXTRANEB nebulizing kit (with mouth piece), ref.

  • Page 9: Performances According To The European Standard En 13544-1 "Nebulizing Systems

    Spare parts:  Mouth piece, ref. C27D  Nasal piece, ref. C26  Adult mask, ref. R  Paediatric mask, ref. RP  Infant mask, ref. RBB,  Mask for tracheotomy, ref. RT  Tube 6x9, 1 metre, ref. C20P ...

  • Page 10: Cleaning And Disinfection

    INSTRUCTIONS FOR USE FOR A GOOD HYGIENE:  Before the first use, disinfect your jet nebulizing kit in boiling water (20 minutes). Require it in its original packaging.  Wash your hand carefully before each inhalation session.  Connect the kit tube(s) to the unit outlet(s) according to the instructions for use that you will find on the compressor and in the kit’s box.

  • Page 11: Failures Remedies And Warranty

    MAINTENANCE OF THE COMPRESSOR The compressor does not need any preventive maintenance. CLEANING OF THE JET NEBULIZING KIT After each treatment, clean the jets by making the nebulizing kit operate with water. Then disconnect the tubes coming from the compressor and clean the nebulizing kit with hot water. The nebulizing kit can be cleaned in the dishwasher.

  • Page 12: Waste Disposal

    CAUTION: In all cases:  WARNING: Always disconnect the electrical cord from the mains supply before opening the body of the compressor (electrical shock hazard).  WARNING: Only a professional repair shop is allowed to repair the device.  WARNING: Modification forbidden. ...

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