Consumables, CPAP,6mos,Phoenix

GENERAL DESCRIPTION
Consumables bundle for the Phoenix nCPAP 300. Bundle is for one CPAP device for an estimated 6 months of use, assuming a 5-day patient stay. This bundle contains nasal cannulas to support neonatal CPAP patients with weights ranging from 700 grams to greater than 2000 grams.

TECHNICAL SPECIFICATIONS
11 x Bubble nasal prong – small (PMS-Y-061) for newborns between 700 – 1250 grams
14 x Bubble nasal prong – medium (PMS-Y-062) for newborns between 1250 – 2000 grams
11 x Bubble nasal prong – large (PMS-Y-063) for newborns greater than 2000 grams
11 x Bonnet – small (bubble type) (PMS-Y-025)
14 x Bonnet – medium (bubble type) (PMS-Y-026)
11 x Bonnet – large (bubble type) (PMS-Y-027)
1 x Reusable bubble CPAP circuit (PMS-YR3)
1 x Reusable humidifier chamber (2010018)
1 x Reusable bubble jar (30230089)
1 x NRV filter – air (NRV/AIR)
1 x NRV filter – oxygen (NRV/O2) 

STORAGE CONDITIONS
Temperature: 5°C - 40°C
Relative Humidity: 10% – 95%

WARRANTY
Includes 2-year standard warranty, dated from the completion of the terms of delivery.

SHELF LIFE
24 months

WEIGHT/VOLUME
Weight: 6kg
Volume: 0.061m³

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.

REGULATION & CONFORMITY REQUIREMENTS
Medical consumables have CE certificate under EU MDD 93/42/ECC or EU MDR 2017/745.