Nebulizer,electric,w/access

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).