Consumables, CPAP,6mos,Diamedica,RAM

GENERAL DESCRIPTION
Consumables bundle for the Diamedica CPAP 20. Bundle is for one CPAP device for an estimated 6 months of use, assuming a 5-day patient stay. This bundle contains RAM-style nasal cannulas to support neonatal CPAP patients with weights ranging from less than 750 grams to greater than 2500 grams.

TECHNICAL SPECIFICATIONS
3 x RAM cannula – micro preemie size (N4900)
3 x RAM cannula – preemie size (N4901)
14 x RAM cannula – newborn size (N4902)
12 x RAM cannula – infant size (N4903)
2 x RAM cannula – small size (N4904)
2 x RAM cannula – medium size (N4905)
36 x Y-piece for RAM cannula (1902000)
2 x Silicone tube, autoclavable (002-002-3150E)
36 x Straight elastomeric connector, single use (1702000)
36 x Bubble PAP valve bottle, single use (AN0018)
1 x Humidifier bottle, autoclavable (H110)
1 x Intake bacteria filter (1025D-605)
1 x Cabinet air filter (303DZ-605)

STORAGE CONDITIONS
Temperature: store within -10 to 40°C (range varies per component) 
Relative humidity: keep dry 

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

SHELF LIFE 
5 years (from date of manufacture of individual components) 

WEIGHT/VOLUME
2 cartons
Total weight: 12.2kg (6.5kg + 5.7kg)
Volume (m³): 0.128m³ (0.064m³ + 0.064m³)

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.