S0002057

Nebulizer,electric,w/access


Nebulizer, two models avaialble: compressor driven or mesh model, portable or hand held, AC powered, with accessories. Indicate any preference when ordering.
Indicative Price 66.02 USD

GENERAL DESCRIPTION
Nebulizer for personal use with two available models: compressor driven or mesh model, portable or hand held, AC powered, with accessories. Not suitable to be used in conjunction with other respiratory support equipment such as: ventilators, anaesthesia machines, CPAP devices, etc.

INTENDED USE
A device designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder, for example chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF).

TECHNICAL SPECIFICATIONS
Nebuliser for the treatment of upper/lower respiratory system and for the delivery of nebulised drugs.
The unit is either compressor driven or uses vibrating mesh technology.
Depending on the model supplied: either portable or a handheld model.
If equipped with a compressor, the compressor is maintenance and oil-free.
Air inlet filter (depending on the model supplied).
Depending on the model supplied: either continuous operation or auto switch off after 20 minutes but allows for immediately restart.
For compressor model: air flow at least 5 L/min.
Minimum drug nebulisation flow greater than: 0.2 ml/min.
Integrated drug reservoir with a minimum capacity: 6 ml.
Residual volume (not operating below) less than 2 ml.
Median Mass Aerodynamic Diameter (MMAD) of particles 2.44 µm.
Noise level ≤ 55 dB
Sturdy construction, suitable to be disinfected with hospital-grade products.
Power requirements: 240 Volts - 50/60 Hz (110 Volt available, specify when ordering).

SUPPLIED WITH
Instructions for assembly, use and maintenance in English.
1 x carry bag (depending on model supplied).
2 x reusable mouthpiece.
2 x air tubing set.
4 x reusable adult face masks.
4 x reusable paediatric face masks.
5 x air filters (depending on the model supplied).
2 x nebuliser tank.

ESTIMATED LIFE SPAN
2 years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 10°C - 40°C / 10% – 93% RH.
- Storage conditions: -20°C - 70°C / 10% – 93% RH.
- Atmospheric pressure: 860 ~ 1060 hPa.
- Ingress protection rating: IP21 or better.

WEIGHT AND VOLUME
Weight: 4.063 kg.
Volume: 58.92 dm³.

ESTIMATED DELIVERY LEAD TIME
120 days.

INSTALLATION REQUIREMENTS
No installation required.

TRAINING REQUIREMENTS
User training is not required.

MAINTENANCE/USER REQUIREMENTS
As per user and service manuals.

COMPONENT OF A KIT
No part of a kit.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier (if not the manufacturer) at a minimum is certified for ISO 9001 Quality management systems – Requirements.

CLASSIFICATION
Classified either under EU MDD 93/42/ECC, or under EU MDR 2017/745 as Class IIa device

SAFETY & PRODUCT STANDARDS
- IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- EN 13544-1:2007 Respiratory therapy equipment - Part 1: Nebulizing systems and their components.

NOMENCLATURE
- GMDN code: Ultrasonic nebulizing system (12719).
- UMDNS code: Nebulizers (12712).

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